Methods and devices for tissue repair

ABSTRACT

An apparatus includes first and second fixation members, a flexible member coupled to the first and second fixation members, and a limiting element coupled to the flexible member. The limiting element is movable relative to the second fixation member and acts to limit loosening of the flexible member relative to the second fixation member. The limiting element can be slidably received by the flexible member. The flexible member can be coupled to the fixation members such that pulling on a free end of the flexible member shortens a length of the flexible member between the fixation members.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of co-pending U.S. application Ser.No. 10/278,474, filed Oct. 23, 2002; which is a continuation-in-part ofU.S. application Ser. No. 09/886,367, filed Jun. 22, 2001, nowabandoned; which is a continuation of U.S. application Ser. No.09/704,926, filed Nov. 2, 2000, now U.S. Pat. No. 7,153,312, and acontinuation-in-part of U.S. application Ser. No. 09/453,120, filed Dec.2, 1999, now abandoned. All of the above applications are incorporatedherein by reference.

TECHNICAL FIELD

This application relates to devices and methods for repairing tissue.

BACKGROUND

One area in the body where soft tissue is surgically reattached to boneis the attachment of a rotator cuff tendon to the humerus. The rotatorcuff tendons have areas of low blood supply. With an increased bloodsupply, a tissue, such as a tendon, can repair and maintain itselfbetter and faster. Thus, areas of poor blood supply in the rotator cuffmake these tendons difficult and slow to heal following an injury, suchas a tear to the supraspinatus muscle or the subscapularis muscle. Insuch a tear, part of the tendon is pulled away from the bone. Because ofthe poor blood supply, rather than attempting to allow an injuredrotator cuff to heal on its own, a physician often recommends that thetendon be surgically repaired to better fix the position of the cuff tothe bone to prevent further damage and improve the environment forhealing. For example, the physician may attempt to fix the tendon to thebone using a retainer such as an anchor. One example of an anchor isdisclosed in U.S. Pat. No. 4,741,330 (the Hayhurst patent), which isincorporated herein by reference.

Other areas in the body also have tissue that can be surgicallyreattached to bone when torn from the bone or can be surgically repairedwhen a tear forms in the tissue. These areas include, for example, thebiceps tendon, the lateral collateral ligament in the knee, the medialcollateral ligament in the knee, the meniscus in the knee, the poplitealligament in the leg, and the labrum tendon in the knee.

Fibrous tissue wounds, such as muscle, ligament, and cartilage tears,can be repaired arthroscopically using sutures. Traditionally, to closea fibrous tissue wound, a surgeon would insert two suture needles intothe tissue with sutures attached, thread the sutures across the wound,and then tie knots to fix the free ends of the sutures within thetissue.

To simplify the wound closure procedure and to improve fixation, varioustypes of retainers have been developed. One example of a retainer isdisclosed in the Hayhurst patent. In the Hayhurst patent, one end of asuture is fixed to a resiliently-deformable, bar-shaped retainer. Theretainer is loaded into the bore of a hollow needle and deployed into oragainst the fibrous tissue. The surgeon then threads the suture acrossthe wound and tensions a free end of the suture to pull the woundclosed. When the surgeon tensions the suture, the bar in the retainerbecomes oriented transversely to the suture hole, anchoring the suturein place.

SUMMARY

In one general aspect, an apparatus includes first and second fixationmembers, a flexible member coupled to the first and second fixationmembers, and a limiting element coupled to the flexible member. Thelimiting element is movable relative to the second fixation member andacts to limit loosening of the flexible member relative to the secondfixation member.

Implementations can include one or more of the following features. Forexample, the limiting element can include a knot formed in the flexiblemember. The knot can include a slip knot.

The limiting element can define a through bore for receiving theflexible member. The limiting element can define an angled channel forreceiving the flexible member. The limiting element can be slidablyreceived on the flexible member.

The flexible member can include a suture. The flexible member can besecured to the first fixation member with a knot. The flexible membercan be movably coupled to the second fixation member with a one-wayknot.

The fixation members can include a cylindrical portion. The secondfixation member can include a T shape. The second fixation member caninclude a crescent shape. The first fixation member can include abutton-shaped portion.

The flexible member can be substantially immovably secured to the firstfixation member. The flexible member can be movably coupled to thesecond fixation member.

At least one of the first and second fixation members can include aretainer. At least one of the first and second fixation members caninclude a fastener.

In another general aspect, an apparatus includes first and secondfixation members, a flexible member coupled to the first and secondfixation members, and a limiting element coupled to the flexible member.The limiting element is slidably received by the flexible member andacts to limit loosening of the flexible member relative to the secondfixation member.

Implementations can include one or more of the following features. Forexample, the limiting element can include a knot formed in the flexiblemember. The knot can include a slip knot.

The limiting element can define a through bore for receiving theflexible member. The limiting element can define an angled channel forreceiving the flexible member. The limiting element can be slidablyreceived on the flexible member.

The flexible member can include a suture. The flexible member can besecured to the first fixation member with a knot. The flexible membercan be movably coupled to the second fixation member with a one-wayknot.

The fixation members can include a cylindrical portion. The secondfixation member can include a T shape. The second fixation member caninclude a crescent shape. The first fixation member can include abutton-shaped portion.

The flexible member can be substantially immovably secured to the firstfixation member. The flexible member can be movably coupled to thesecond fixation member. At least one of the first and second fixationmembers can include a retainer. At least one of the first and secondfixation members can include a fastener.

In another general aspect, an apparatus includes a fixation member, anda flexible member movably coupled to the fixation member. A first end ofthe flexible member is looped back and secured to the flexible memberfor forming a loop. The loop is remote from the fixation member.

In another general aspect, a surgical assembly includes a firstfastener, a second fastener, and a flexible member connecting the firstfastener to the second fastener. The flexible member is movably attachedto the second fastener, such that pulling on a free end of the flexiblemember shortens a length of the flexible member between the first andsecond fasteners.

Implementations can include one or more of the following features. Forexample, the first fastener can include a first screw, and the secondfastener can include a second screw.

The movable attachment of the flexible member to the second fastener canenable the length of the flexible member between the first and secondfasteners to be shortened, but not lengthened. The movable attachmentcan include a knot formed in the flexible member at the second fastener.

The knot can includes a first portion of the flexible member that formsa loop, and a second portion that passes over a surface of the secondfastener and through the loop. The surface can comprise an exteriorsurface of the second fastener. The second portion can include the freeend. The knot can be configured such that pulling on the free end causesthe flexible member to slide through the loop to shorten the length ofthe flexible member between the first and second fasteners, but pullingon the flexible member in an opposite direction in order to increase thelength of the flexible member between the first and second fastenerscauses the loop to press the second portion against a compressionsurface of the second fastener, resisting increase in the length of theflexible member between the first and second fasteners.

The second fastener can define a partially enclosed region, and the loopcan be formed within the partially enclosed region. The second fastenercan include a first section that defines a plurality of holes, and thefirst portion of the flexible member can pass through the plurality ofholes to form the loop.

The second fastener can include a second section that defines a passagethat connects to the partially enclosed region, and the free end of thesuture can pass through the passage.

The second fastener can further include a rounded body and an appendageattached to the rounded body, the rounded body and the appendagedefining a partially enclosed region therebetween, wherein at least aportion of the flexible member passes through the partially enclosedregion. The flexible member can wrap around the rounded body. Therounded body can have a generally cylindrical shape, and can be sizedand shaped to fit within the bore of a hollow needle. The rounded bodycan define an axial groove, the groove extending across an axial lengthof the rounded body.

The appendage can have a cross-sectional shape selected from the groupconsisting of a rectangle, an L, and a D.

The flexible member can be movably attached to the second fastener toform a knot, the knot allowing the length of the flexible member betweenthe first and second fasteners to be shortened, but not lengthened, andthe knot including the portion of the flexible member that passesthrough the partially enclosed region.

The second fastener can have a generally hemispherical shape or agenerally crescent shape. The second fastener can have a sharp tipconfigured to penetrate tissue. The second fastener can be generallyT-shaped. The second fastener can define a through-hole, and theflexible member can pass through the through-hole. The surgical assemblycan also include a second flexible member that passes through thethrough-hole, the second flexible member having a thickened portion thathas a width greater than a width of the through-hole, such that thethickened portion cannot pass through the through-hole.

The first fastener can include a generally cylindrical body, the bodybeing sized and shaped to fit within a bore of a hollow needle. Thefirst fastener can include a projection extending from the cylindricalbody. The projection can include a longitudinal fin. The projection candefine a hole for passage of the flexible member therethrough.

The first fastener can have a button shape, and can define a hole forpassage of a suture therethrough.

The flexible member can be fixed to the first fastener. The flexiblemember can include a suture.

The surgical assembly can include a limiting element coupled to theflexible member, the limiting element being slidably received by theflexible member and acting to limit loosening of the flexible memberrelative to the second fixation member.

The surgical assembly can include a limiting element coupled to theflexible member, the limiting element being movable relative to thesecond fixation member and acting to limit loosening of the flexiblemember relative to the second fixation member.

In another general aspect, a wound closure kit includes a needle havingan open tip and defining a longitudinal bore that connects to the opentip, first and second fasteners disposed within the needle bore, and aflexible member connecting the first fastener to the second fastener.

Implementations can include one or more of the following features. Forexample, the needle can define a longitudinal slit that connects to thebore and to the open tip. The first fastener can include a projectionthat protrudes through the slit. The second fastener can include anappendage that protrudes through the slit, and the flexible member canbe attached to the appendage.

The flexible member can be fixed to the first fastener, and movablyattached to the second fastener. The flexible member can include asuture.

In another general aspect, a method of closing a tissue wound includesproviding a wound closure device having a first fastener, a secondfastener, and a flexible member movably attached to the second fastener.The method also includes positioning the first fastener against tissue,passing the flexible member across the wound, positioning the secondfastener against tissue, and pulling on a free end of the flexiblemember to shorten a length of the flexible member between the first andsecond fasteners, thereby closing the wound.

Implementations can include one or more of the following features. Forexample, the flexible member can be slidably attached to the secondfastener by a one-way knot, such that after completion of the pullingstep, the length of the flexible member between the first and secondfasteners remains shortened.

The first positioning step can include positioning the first fastener ona first side of the wound. The passing step can include passing theflexible member from the first side to a second side of the wound,engaging tissue on the second side, and returning the flexible member tothe first side. The second positioning step can include positioning thesecond fastener on the first side of the wound.

The providing step can include providing a needle having an open tip anddefining a bore that connects to the open tip, the first and secondfasteners being at least partially disposed within the bore.

The needle can define a slit that connects to the bore and to the opentip, the first fastener can include a projection that protrudes throughthe slit, and the first positioning step can include engaging theprojection with tissue to remove the first fastener from the bore.

The providing step can include providing a second fastener that definesa partially enclosed region, the partially enclosed region housing atleast a portion of the one-way knot, and the partially enclosed regionbeing located such that during the pulling step, the portion of theone-way knot disposed within the partially enclosed region avoidscontact with tissue.

The providing step can include providing a device in which the flexiblemember passes through a through-hole in the second fastener, and thedevice can also include a second flexible member that also passesthrough the through-hole, the second flexible member having a thickenedportion that is wider than the through hole. The method can also includepulling the second flexible member until the thickened portion wedgesinto the through hole.

In another general aspect, a method of repairing a tear in a meniscusincludes providing a tear closing device having a first fastener, asecond fastener, and a flexible member movably attached to the secondfastener. The method also includes positioning the first fasteneragainst the meniscus, passing the flexible member across the tear,positioning the second fastener against the meniscus, and pulling on afree end of the flexible member to shorten a length of the flexiblemember between the first and second fasteners, thereby closing the tear.

Implementations can include one or more of the following features. Forexample, the providing step can include providing a tear closing devicein which the flexible member is fixed to the first fastener. The firstpositioning step can include positioning the first fastener against anexternal surface of the meniscus, on a first side of the tear. Thepassing step can include passing the flexible member from the first sideto a second side of the tear, engaging tissue on the second side, andreturning the flexible member to the first side. The second positioningstep can include positioning the second fastener against the externalsurface.

The first and second fasteners can be positioned against externalsurfaces of the meniscus on opposite sides of the tear.

In another general aspect, a surgical method includes positioning afixation member relative to tissue, moving a flexible member coupled tothe fixation member relative to the fixation member to bring two tissuesurfaces together, and moving a limiting element coupled to the flexiblemember relative to the fixation member. The limiting element acts tolimit loosening of the flexible member relative to the fixation member.

Implementations can include one or more of the following features. Forexample, the step of moving the flexible member can include pulling theflexible member. The step of moving the flexible member can alsoaccomplish the step of moving the limiting element.

The surgical method can also include providing the limiting element inthe form of a slip knot.

The step of moving the limiting element can include moving the limitingelement relative to the flexible element. The surgical method caninclude providing the limiting element in the form of a friction elementthat permits sliding of the limiting element relative to the flexibleelement in only one direction.

The surgical method can include providing the limiting element in theform of an overhand knot. The surgical method can include advancing theoverhand knot along the flexible element. The surgical method caninclude providing the limiting element in the form of a Chinese trap.

The step of moving the flexible member can include pulling on only oneend of the flexible member.

The surgical method can include positioning a second fixation memberrelative to the tissue, the second fixation member being coupled to theflexible member. The second fixation member can be movably coupled tothe flexible member, and the step of moving the flexible member caninclude pulling on two ends of the flexible member. The second fixationmember can be fixedly attached to the flexible member, and the step ofmoving the flexible member can include pulling on only one end of theflexible member.

The step of positioning the fixation member can include positioning thefixation member on an outer surface of the tissue. The two tissuesurfaces can be both soft tissue. The step of positioning the fixationmember can include positioning the fixation member in a bone hole.

A first of the two tissue surfaces can be bone, and a second of the twotissue surfaces can be soft tissue.

The step of positioning the fixation member can include passing thefixation member through a loop of the flexible member. The surgicalmethod can also include positioning the loop within a tear in softtissue.

In another general aspect, a method for repairing a tear in soft tissueincludes advancing a fixation member coupled to a flexible memberthrough tissue on either side of the tear and through a loop of theflexible member, and tensioning the flexible member to bring two tissuesurfaces on either side of the tear together.

Implementations can include one or more of the following features. Forexample, the method can include positioning the loop within the tear.The method can include pulling an end of the flexible member to bringthe two tissue surfaces together. The method can include providing thefixation member in the form of a barbed member.

In another general aspect, a surgical assembly includes a fastenerconfigured to be secured within bone tissue, a retainer for engagingtissue, and a flexible member connecting the fastener to the retainer.The flexible member is movably attached to the retainer such thatpulling on a free end of the flexible member shortens a length of theflexible member between the fastener and the retainer to urge the tissueagainst the bone tissue.

Implementations can include one or more of the following features. Forexample, the movable attachment of the flexible member to the retainercan be configured to enable the length of the flexible member betweenthe fastener and the retainer to be shortened, but not lengthened.

The movable attachment can include a knot formed in the flexible member.The knot can include a slip knot. The flexible member can include asuture.

The retainer can include a smooth first surface and a second surfacethat includes protrusions. The retainer can include a smooth firstsurface and a second surface having a length and protrusions that aretransverse to the length of the second surface. The retainer can have alow profile such that the retainer does not protrude sufficiently fromthe tissue to impinge against adjacent tissue. The retainer can have athickness of between approximately 0.5 and 2.5 millimeters. The retainercan have a thickness of approximately 2 millimeters.

The fastener can include a screw. The screw can include a threaded shankand a head, and the head can define at least one opening and theflexible member can pass through the opening. The screw can include aridge between the shank and the head.

The surgical assembly can include a delivery device for delivering thefastener and the retainer to a surgical site. The delivery device caninclude a cannula defining a lumen for receiving the fastener and theretainer.

The surgical assembly can include a retractable needle positioned withinthe lumen and connected to a switch in the delivery device for advancingand retracting the needle.

In another general aspect, a surgical method includes positioning afastener within bone tissue, positioning a retainer against soft tissueto be attached to the bone tissue, the fastener and retainer beingconnected by a flexible member, the flexible member being movablyattached to the retainer, and pulling a free end of the flexible memberto shorten a length of the flexible member between the fastener and theretainer to urge the soft tissue against the bone tissue.

Implementations can include one or more of the following features. Forexample, the movable attachment of the flexible member to the retainercan enable shortening but not lengthening of the length of the flexiblemember between the fastener and the retainer. The movable attachment caninclude a slip knot formed in the flexible member and pulling the freeend can move the slip knot along the flexible member.

The positioning of the fastener within bone tissue can include rotatablyinserting the fastener into bone tissue.

The positioning of the retainer against soft tissue can include locatingthe retainer within a needle, passing the needle through the soft tissuesuch that a protrusion on the retainer passes through at least a portionof the soft tissue, and withdrawing the needle from the soft tissue suchthat the retainer is pulled from the needle by the interaction of theprotrusion and the soft tissue. The surgical method can also includepositioning a second retainer against the tissue on a side of the tissueopposite that of the first retainer. The second retainer can bepositioned within the needle, the flexible member can connect the secondretainer to the first retainer and the fastener, and withdrawing theneedle from the tissue can cause the flexible member to be under tensionsuch that the second retainer is pulled from the needle.

The pulling of the free end of the flexible member can move a slip knotalong the flexible member, the slip knot being positioned between thefree end of the flexible member and the second retainer.

The retainer can have a low profile such that the retainer does notprotrude sufficiently to impinge against adjacent tissue when theretainer is positioned against soft tissue. The retainer can have athickness of between approximately 0.5 and 2.5 millimeters.

The retainer can have a thickness of approximately 2 millimeters.

In another general aspect, a surgical assembly includes a deliverydevice including a handle and a cannula, the cannula extending from thehandle and including a longitudinal channel and a longitudinal slot inthe cannula along at least a portion of the length of the channel, and asurgical device including a first fixation member, a second fixationmember, a flexible member coupling the first fixation member and thesecond fixation member, the flexible member being movably attached tothe first fixation member such that pulling on a free end of theflexible member shortens a length of the flexible member between thefirst fixation member and the second fixation member. The first fixationmember is positioned within the longitudinal channel, the secondfixation member is positioned adjacent to an outer surface of thecannula, and the flexible member passes from the longitudinal channelthrough the longitudinal slot.

Implementations can include one or more of the following features. Forexample, the surgical assembly can include a pusher tube slidablypositioned within the cannula and including a thumb switch extendingthrough the longitudinal slot for advancing and retracting the pushertube.

The movable attachment can include a slip knot. The movable attachmentcan be positioned within the longitudinal channel. The movableattachment can be positioned outside of the longitudinal channel.

In another general aspect, a surgical method includes drilling a channelthrough bone tissue and soft tissue and pulling a first flexible memberto pull a fastener in a first direction through the channel such thatthe fastener passes through the bone tissue and the soft tissue. Themethod includes pulling a second flexible member to pull the fastener ina second direction against the soft tissue, the second flexible memberconnecting the fastener to a retainer. The method also includes pullinga free end of the second flexible member to shorten a length of thesecond flexible member between the fastener and the retainer, wherebypulling the free end of the second flexible member positions theretainer against the bone.

In another general aspect, a surgical method includes positioning afastener within bone tissue, positioning a first retainer against softtissue to be attached to the bone tissue, the fastener and firstretainer being movably attached by a flexible member, positioning asecond retainer against soft tissue to be attached to the bone tissue,the fastener, the first retainer, and the second retainer being movablyattached by the flexible member, and pulling a free end of the flexiblemember to shorten a length of the flexible member between at least anytwo of the fastener, the first retainer and the second retainer.

Implementations can include one or more of the following features. Forexample, the movable attachment of the flexible member to the retainercan enable shortening but not lengthening of the length of the flexiblemember between any two of the fastener, the first retainer, and thesecond retainer. The pulling of the free end of the flexible member canmove a slip knot along the flexible member, the slip knot beingpositioned between the free end of the flexible member and the secondretainer. The positioning of the fastener within bone tissue can includerotatably inserting the fastener into bone tissue.

The positioning of either of the first retainer and the second retaineragainst soft tissue can include locating the retainer within a needle,passing the needle through the soft tissue such that a protrusion on theretainer passes through at least a portion of the soft tissue, andwithdrawing the needle from the soft tissue such that the retainer ispulled from the needle by the interaction of the protrusion and the softtissue.

The pulling of a free end of the flexible member can include moving aslip knot positioned between a free end of the flexible member and thesecond retainer along the flexible member to shorten a length of theflexible member between at least any two of the fastener, the firstretainer, and the second retainer.

In another general aspect, a surgical method includes positioning afastener within bone tissue, and advancing a delivery device including aneedle under a first soft tissue member. The method includes advancingthe curved delivery device through a second soft tissue member andpositioning a retainer against the second soft tissue member. Thefastener and retainer are connected by a flexible member, and theflexible member is movably attached to the retainer. The method alsoincludes pulling a free end of the flexible member to shorten a lengthof the flexible member between the fastener and the retainer.

Implementations can include one or more of the following features. Forexample, the movable attachment of the flexible member to the retainercan enable shortening but not lengthening of the length of the flexiblemember between the fastener and the retainer.

The pulling of the free end can move the slip knot along the flexiblemember, the slip knot being formed in the flexible member.

The positioning of the fastener within bone tissue can include forciblyinserting the fastener into bone tissue.

The positioning of the retainer against the second soft tissue caninclude locating the retainer within the needle, passing the needlethrough the second soft tissue such that a protrusion on the retainerpasses through at least a portion of the second soft tissue, andwithdrawing the needle from the second soft tissue such that theretainer is pulled from the needle by the interaction of the protrusionand the second soft tissue.

The delivery device can be advanced under the first soft tissue memberand the retainer can be positioned against the second soft tissue memberprior to positioning the fastener within the bone tissue.

In another general aspect, a surgical method for repairing a meniscaltear includes positioning a delivery device having a needle against afirst position on soft tissue, and advancing the needle through the softtissue. A first fixation member is positioned within a longitudinalchannel of a lumen of the needle and includes a protrusion extendingfrom the first fixation member through a longitudinal slot in theneedle. The method includes withdrawing the needle from the soft tissuesuch that the first fixation member is pulled from the needle by theinteraction of the protrusion and the soft tissue. The method alsoincludes positioning the delivery device against a second position onthe soft tissue, and advancing the delivery device and the needlethrough the soft tissue. A second fixation member is positioned withinthe longitudinal channel of the lumen and includes a protrusionextending from the second fixation member through the longitudinal slotin the needle. The method includes withdrawing the delivery device fromthe soft tissue such that the second fixation member is pulled from theneedle by the interaction of the protrusion and the soft tissue.

Implementations can include one or more of the following features. Forexample, the positioning of the first fixation member and the secondfixation member can include positioning the first fixation member andthe second fixation member on opposite sides of the meniscal tear. Thepositioning of the first fixation member and the second fixation membercan include positioning the first fixation member and the secondfixation member on the same side of the meniscal tear.

In another general aspect, a device for repairing a tear in a tissueincludes a needle having a distal region and a proximal region, thedistal region being defined between two holding elements, a firstfixation member positioned within the distal region and a secondfixation member positioned within the proximal region, and a flexiblemember coupled to the first and second fixation members.

Implementations can include one or more of the following features. Forexample, one of the holding elements can include a crimp in the needlein the distal region. One of the holding elements can include a dimpleextending into a lumen of the needle. One of the holding elements caninclude a ramp extending into a lumen of the needle.

The needle can define a slot through a wall of the needle, the first andsecond fixation members extending through the slot.

The device can also include a protector tube, the tube defining a bore,wherein the needle is sized to fit into an end of the protector tube.The device can include a push pin, the pin being sized to fit inside theneedle.

Embodiments can include one or more of the following advantages. Thefirst and second fixation members can be deployed using a single hollowneedle, rather than two separate needles. After deploying a fixationmember, the surgeon need not tie an additional knot. The length of aflexible member coupled to the fixation member can be adjusted afterdeploying the fixation member, allowing a surgeon to set the tension inthe flexible member to a desired level. The length of a flexible memberspanning across a tear in tissue can be shortened to close the tear bytensioning the flexible member with no additional manipulation beingrequired to limit loosening of the flexible member.

Since the device uses a flexible member, such as a suture, to close thetissue wound, rather than inflexible staples or tacks, the tissue is notsignificantly damaged when it expands and contracts. For example, if thesoft tissue is a meniscus, the fixation members do not damage themeniscal tissue when the knee moves.

Additionally, the physician does not need to tie any knots and thefixation members have a low profile, which limits protrusion of thefixation members into the joint capsule. For example, the devices andmethods provide an optimal repair and reattachment of soft tissue tobone by first providing optimal fixation when the devices are placed andthen providing an easily manipulated limiting elements (for example, theslip knot) that fixes the position of the fixation members against thebone and tissue. Because the system uses optimal fixation prior totightening the slip knot, a fixation members can be used in bone tissuethat has a less than optimal tissue condition, such as osteoporoticbone.

Moreover, the procedure is simple and easy. For example, in oneembodiment, the fastener is rotatably positioned within the bone, thedelivery device is withdrawn, a knot pusher is used to tighten the slipknot to place the retainer against the tendon, and the proximal end ofthe suture is cut. Thus, the physician does not need to tie any knots orreach through tissue to manipulate any of the components used in theprocedure.

Other features will be apparent from the description, the drawings, andthe claims.

DESCRIPTION OF DRAWINGS

FIG. 1 is an illustration of a closure device, shown mending a tear insoft tissue.

FIGS. 2A-2I show a method of tying a slip knot in suture of the closuredevice of FIG. 1.

FIG. 3 is a perspective view of a delivery device for inserting theclosure device of FIG. 1 into soft tissue.

FIG. 4 is a perspective view of the delivery device of FIG. 3 shown withan outer sheath removed.

FIG. 4A is a perspective view of a fixation member of the closure deviceof FIG. 1.

FIG. 4B is a cross-sectional end view of the delivery device of FIG. 4,taken along lines 19B-19B.

FIG. 4C is a cross-sectional side view of an alternative embodiment of aneedle of the delivery device of FIG. 3.

FIG. 5 is side view of the delivery device of FIG. 3.

FIG. 5A is a side view of a variable length depth stop for use with thedelivery device of FIG. 3.

FIG. 5B is a perspective view of a cannula for use with the deliverydevice of FIG. 3.

FIGS. 6-11 show the delivery device in use inserting the closure deviceof FIG. 1 in soft tissue, with FIG. 7 being an exploded view of region 7of FIG. 6.

FIG. 12 is an illustration of the closure device of FIG. 1 with analternative embodiment of a limiting element, shown mending a tear insoft tissue.

FIGS. 12A and 12B show alternative embodiments of the limiting elementof FIG. 11.

FIG. 12C shows the limiting element of FIG. 12 in an alternativeposition.

FIG. 13 shows an additional alternative embodiment of a limiting elementin the form of an overhand knot.

FIGS. 13A and 13B show an overhand knot and a knot pusher for advancingthe overhand knot of FIG. 13.

FIG. 14 is an illustration of an alternative embodiment of a closuredevice.

FIG. 14A shows an alternative arrangement of the closure device anddelivery device of FIG. 14.

FIG. 14B is an illustration of an alternative embodiment of a closuredevice.

FIG. 15A is a perspective view of a wound closure device.

FIG. 15B is a side view of a first fixation member of the wound closuredevice of FIG. 15A.

FIG. 15C is a side view of a second fixation member of the device ofFIG. 15A.

FIG. 15D is an enlarged view of a braided suture.

FIG. 16 is a perspective, cut-away view of a meniscus in which the woundclosure device of FIG. 15A has been implanted.

FIGS. 17A and 17B are sectional views of, respectively, a secondfixation member and one-way knot of the wound closure device of FIG.15A.

FIG. 18 is a perspective view of a hollow needle, with the wound closuredevice of FIG. 15A disposed within a bore of the needle.

FIGS. 19A-19D are schematics illustrating deployment of the woundclosure device of FIG. 15A into a meniscus using a plunger.

FIGS. 20A-20D are schematics illustrating deployment of the woundclosure device of FIG. 15A into a meniscus using a plunger and a spacer.

FIG. 21 A is a perspective view of an alternative first fixation memberdesign for a wound closure device, used in reverse deployment of thedevice.

FIGS. 21B-21E are schematics illustrating reverse deployment of a woundclosure device.

FIGS. 22A and 22B are perspective views of the second fixation member ofFIGS. 15A and 15C, showing an alternative one-way knot configuration forthe fixation member.

FIGS. 23-26 are perspective views of alternative configurations of thefixation member and one-way knot of FIGS. 17A and 17B.

FIG. 27A is a top view of a T-shaped second fixation member.

FIG. 27B is a side view of the T-shaped fixation member of FIG. 27A.

FIG. 27C is a front view of a crescent-shaped second fixation member.

FIG. 27D is a side view of the crescent-shaped fixation member of FIG.27C.

FIGS. 28-30 are sectional views showing deployment of wound closuredevices that include the crescent-shaped fixation member of FIG. 27C.

FIG. 31 is a perspective, partially schematic view of an alternativewound closure device implanted within a meniscus.

FIG. 32A is a perspective view of an alternative first fixation memberdesign for a wound closure device.

FIG. 32B is a perspective, cut-away view of a meniscus in which thewound closure device of FIG. 33A has been implanted.

FIG. 33 is a cross-sectional side view of an alternative embodiment of aclosure device, shown mending a tear in soft tissue.

FIG. 34 shows the closure device of FIG. 33 in use prior to securing theclosure device in place.

FIG. 35 is a top view of the closure device of FIG. 33, shown aftersecuring the closure device in place.

FIG. 36 is a side view of a delivery device for inserting the closuredevice of FIG. 33 in soft tissue.

FIG. 36A is a perspective view of a distal section of the deliverydevice of FIG. 36 shown with a fixation member of the closure device ofFIG. 33.

FIG. 36B is a perspective view similar to that of FIG. 36A shown withthe closure device of FIG. 33.

FIG. 36C is an illustration of the closure device of FIG. 33.

FIGS. 37-39 show the delivery device of FIG. 36 in use inserting theclosure device of FIG. 33 in soft tissue.

FIG. 40 is a cross-sectional side view of the closure device of FIG. 33with an alternative embodiment of a limiting element, shown mending atear in soft tissue.

FIG. 41 is a cross-sectional side view of an alternative embodiment of aclosure device, similar in use to the closure device of FIG. 33.

FIGS. 42 and 43 are alternative embodiments of a fixation member of theclosure device of FIG. 33.

FIG. 44 illustrates an alternative embodiment of a surgical device thatincludes two fixation members, a suture, and a slip knot.

FIG. 45 illustrates the surgical device of FIG. 44 used to repair ameniscal tear.

FIG. 46 is a cross-sectional side view of the surgical device of FIG. 44shown positioned within the delivery device for delivering the surgicaldevice to a surgical site.

FIG. 47 is a top view of the surgical device and delivery device of FIG.46.

FIGS. 48-51 illustrate the surgical device and delivery device of FIG.46 in use repairing a tear in meniscal tissue.

FIG. 52 is a cross-sectional side view of an alternative embodiment of adelivery device for the surgical device of FIG. 44.

FIG. 53 is a cross-sectional side view of another alternative embodimentof a delivery device for the surgical device of FIG. 44.

FIG. 54 is a side view of a surgical device for repairing a meniscaltear.

FIG. 55 is a cross-sectional side view of a delivery device fordelivering the surgical device of FIG. 54.

FIGS. 56-58 illustrate a first placement of the surgical device of FIG.54 in the meniscus to repair a meniscal tear.

FIG. 59 illustrates a second placement of the surgical device of FIG. 54in the meniscus to repair a meniscal tear.

FIG. 60 is a surgical device attaching soft tissue to bone.

FIG. 61 is a fastener, a suture, and a fixation member of the device ofFIG. 60.

FIG. 62 is a side view of the device of FIG. 1 and a delivery device fordelivering the surgical device to a surgical site.

FIG. 63 is a perspective view of a slip knot in the suture of thesurgical device of FIG. 60.

FIG. 64 is a side view of the fastener of the surgical device of FIG.60.

FIG. 65 is a top view of the fastener of FIG. 64.

FIG. 66 is a cross-sectional side view of the delivery device of FIG.62.

FIG. 67 is an end view of the delivery device of FIG. 66 taken atsection lines 67-67 of FIG. 66.

FIG. 68 is a cross-sectional side view of the distal end of the deliverydevice illustrating the surgical device of FIG. 60 positioned within thedelivery device.

FIGS. 69-72 are top, bottom, side, and end views, respectively, of thefixation member of the surgical device of FIG. 60.

FIG. 73 is a perspective view of the fixation member illustrating thepassage of the suture through channels or openings in the fixationmember.

FIGS. 74-76 are perspective bottom, perspective top, and cross-sectionalside views, respectively, of an alternative embodiment of a fixationmember having a tissue contacting surface with protrusions.

FIG. 77 is a perspective bottom view of an oblong fixation member havinga smooth bottom surface.

FIGS. 78-80 are perspective bottom views of oblong fixation membershaving bottom surfaces with protrusions.

FIGS. 81-84 illustrate an arthroscopic procedure to repair a rotatorcuff injury using the device of FIG. 62.

FIG. 85 is a cross-sectional side view of an alternative embodiment of asurgical assembly for placing a fastener and one or more retainers.

FIGS. 86 and 87 are side and top views of a retractable needle andhandle of a delivery device of the surgical assembly of FIG. 85.

FIG. 88 shows a distal region of the surgical assembly of FIG. 85illustrating the fastener and two barbed retainers positioned in thedelivery device.

FIG. 89 illustrates the arrangement of the fastener, barbed retainers,and suture of the surgical device of FIG. 85.

FIGS. 90-97 illustrate a tissue repair procedure using the surgicalassembly of FIG. 85.

FIGS. 98 and 99 are an alternative embodiment of a surgical assemblyincluding a fastener and a barbed retainer connected by a suture havinga slip knot.

FIG. 100 illustrates an alternative embodiment of a surgical assemblyincluding a pair of fasteners connected by a suture having a slip knot.

FIGS. 101 and 102 illustrate top and bottom views, respectively, of thefastener of FIG. 100.

FIGS. 103 and 104 illustrate end views of two implementations of acannula of a delivery device of the surgical assembly of FIG. 41.

FIG. 105 is an illustration of an alternative embodiment of a closuredevice for use in attaching soft tissue to bone.

FIG. 106 is a side view of a knee joint in which there is laxity in thelateral collateral ligament.

FIG. 107 is a top view of a surgical assembly that includes a deliverydevice and a surgical device for repairing laxity in the lateralcollateral ligament of FIG. 106.

FIG. 108 is a side view of the surgical assembly of FIG. 107.

FIG. 109 is a cross-sectional side view of the distal end of thesurgical device of FIG. 107.

FIGS. 110-114 illustrate the surgical device of FIG. 107 in userepairing laxity in the lateral collateral ligament of FIG. 106.

FIG. 115 is a cross-sectional side view of the distal end of a modifiedversion of the surgical device of FIG. 107.

FIGS. 116 and 117 illustrate the surgical device of FIG. 115 in userepairing laxity in the lateral collateral ligament of FIG. 106.

FIG. 118 illustrates a surgical device having a button-shaped fastener.

FIG. 119 illustrates the drilling of a channel through the tibia andfemur.

FIG. 120 is a side view of a drill used to perform the drilling of FIG.119.

FIGS. 121-123 illustrate the placement of the surgical device of FIG.118 in the knee joint to repair a torn meniscus.

FIGS. 124-127 illustrate the placement of the surgical device of FIG.118 in the shoulder joint to repair a torn rotator cuff.

Like reference symbols in the various drawings indicate like elements.

DETAILED DESCRIPTION

Referring to FIG. 1, a closure device 8 for mending a tear 12 in softtissue 14, for example, the meniscus of the knee joint, includes aflexible member, for example, suture 10, coupled to a first fixationmember (for example, a first retainer) 16 and a second fixation member(for example, a second retainer) 18. The meniscus is a C-shaped,rubbery, shock-absorbing structure located between the tibia and thefemur inside the knee. Suture 10 is fastened to fixation member 16 tolimit movement of suture 10 relative to the first fixation member 16,while suture 10 is movable relative to the second fixation member 18.

When implanted in the knee joint, the fixation members 16 and 18 lie ona surface 20 of tissue 14, for example, the outer surface of themeniscus. Suture 10 has a first suture length 10 a extending from firstfixation member 16 through tissue 14, traversing the tear 12, andemerging at a surface 26 of tissue 14; a second suture length 10 bextending across the surface 26; a third suture length 10 c extendingback through tissue 14, traversing the tear 12 at a location spaced fromthe first length 10 a, and emerging at the tissue surface 20 wheresuture 10 loops through the second fixation member 18; and a fourthsuture length 10 d extending from the second fixation member 18 throughtissue 14, traversing the tear 12, and emerging at the surface 26.Suture 10 has a free end 30 that the surgeon pulls, in the direction ofarrow 32, to bring sides 22, 24 of the tear 12 together intojuxtaposition (as shown in FIG. 11).

As described further below, the suture portion 10 c and the sutureportion 10 d are tied together prior to implantation of the device 8 toform a limiting element in the form of a slip knot 28 that allows suture10 to be pulled in the direction of arrow 32, but does not allow tensionon suture 10 to pull suture 10 in the opposite direction, which wouldallow the tear 12 to reopen.

Referring to FIGS. 2A-2I, prior to insertion into tissue 14, suture 10is attached to the fixation members 16, 18 and the slip knot 28 isformed. The fixation member 16 defines holes 16 a, 16 b for receivingsuture 10, and the fixation member 18 defines holes 18 a, 18 b (shown inFIGS. 2E and 2F) for receiving suture 10. As illustrated in FIGS. 2A-2D,suture 10 is attached to the fixation member 16 by threading suture 10through a needle 50, and passing the needle 50 and suture 10 through theholes 16 a, 16 b in the fixation member 16 (FIG. 2A). Suture 10 nowdefines a long suture section 52 and a short suture section 54. The longsuture section 52 is then attached to the short suture section 54 bypassing the needle 50 and the long suture section 52 through the shortsuture section 54 at a region 56 (FIG. 2B). Pulling the long suturesection 52 away from the fixation member 16 (FIG. 2C) then draws theregion 56 toward the fixation member 16 forming a knot 60 (FIG. 2D).Suture 10 is now secured to the fixation member 16.

Referring to FIGS. 2E-2I, suture 10 is now attached to the fixationmember 18 by passing the long suture section 52 through the holes 18 a,18 b in the second fixation member 18 (FIG. 2E). The long suture section52 now defines a first suture length 62 and a second suture length 64.The slip knot 28 (FIG. 21) is formed by passing the fixation member 16under the suture length 64, over the suture length 64, and under thesuture length 62, forming a loop 66 (FIG. 2F); then passing the fixationmember 16 over the suture lengths 62 and 64, forming a loop 68 (FIG.2G); and then passing the fixation member 16 under the suture lengths 64and 62 (FIG. 2G), and finally through the loop 68 (FIG. 2H). Pulling thefixation member 16 relative to the fixation member 18 tightens the slipknot 28 (FIG. 21). Pulling the free end 30 of suture 10 now acts toslide suture 10 through the slip knot 28, while the slip knot 28 limitssliding of suture 10 in the opposite direction when suture 10 is undertension.

Referring to FIG. 3, a delivery device 99 for implanting the device 8 intissue 14 includes a sheath 200 and a needle 100. The sheath 200 ispreferably formed from plastic, and the needle 100 is preferably metal.The needle 100 has an open distal end 111 with a pointed, tissuepiercing tip 108. The needle 100 has an inner surface 102, defining alumen 104, and a slot 110, both the inner surface 102 and the slot 110extending to the open distal end 111. The slot 110 extends from an outersurface 106 of the needle 100 to the lumen 104. As described furtherbelow, the needle 100 receives the fixation members 16 and 18 within thelumen 104 and the slot 110 with suture 10 tied to the fixation members16, 18 as illustrated in FIGS. 2A-2I. The sheath 200 defines a lumen 202that receives the needle 100 and the device 8 with suture 10 positionedbetween the needle 100 and the sheath 200 and extending through a hole201 defined at a proximal end 203 of the sheath 200. The sheath 200 hasa distal end 204 from which the needle 100 extends.

Referring also to FIGS. 4-4B, the slot 110 has a proximal, closed end120 and a distal open end 140. The fixation members 16 and 18 (which aregenerally described in U.S. application Ser. No. 09/453,120, supra) havethe same shape with each fixation member including a cylindrical region151 received within the lumen 104 of the needle 100, and a fin 152extending through the slot 110 with a portion 154 of the fin 152extending beyond the outer surface 106 of the needle 100. The fixationmember 16 is located at a distal region 112 of the slot 110, and thefixation member 18 is located at a proximal region 114 of the slot 110.The distal end 111 of the needle 100 is indented, for example, crimpedat 150, and the inner surface 102 of the needle 100 has a protrusionextending into lumen 104, for example, a dimple 130, near the distal end140. The dimple 130 and the crimp 150 are sized to resist unintentionalpassage of the fixation members either over the dimple 130 or throughthe open distal end 111, though only a small force on the fixationmembers is needed to overcome the resisting load applied to the fixationmembers by the crimp 150 and the dimple 130. As shown in FIG. 4A, thefixation members 16, 18 have sloped surfaces 152 a that aid in passagethrough tissue, and flat surfaces 154 a that aid in retention of thefixation members at their deployment sites.

During manufacturing, to position the fixation members 16, 18 in theneedle 100, after suture 10 is attached to the fixation members 16, 18,the fixation member 18 is loaded in the needle 100 by passing thefixation member 18 through the distal end 111 and sliding the fixationmember 18 along the lumen 104 and the slot 11O to the proximal end 120of the slot 110. The fixation member 16 is then loaded in the needle 100by passing the fixation member 16 through the distal end 111 andpositioning the fixation member 16 in the region 112. The dimple 130 andthe crimp 150 are then formed. The fixation member 16 is now restrainedfrom unintentional movement in the proximal direction by the dimple 130and in the distal direction by the crimp 150.

Alternatively, as shown in FIG. 4C, rather than dimple 130, a needle 100a includes a ramp 130 a formed by making three slits in a wall 101 ofthe needle 100 a and bending a section of the wall toward the inside ofthe needle 100 a.

Referring also to FIG. 5, the needle 100 has a proximal end 160 mountedto a handle 180. Located within the needle 100, proximal of the fixationmember 18, is a push rod 170 (FIG. 4) used to advance the fixationmember 18, as described below. The handle 180 includes an actuatingslider 190 attached to the push rod 170 for advancing the push rod 170.Once the device 8 is secured to the needle 100, as described above, thesheath 200 is placed over the needle 100, with the majority of suture 10located within and protected by the sheath 200. The sheath 200 alsocovers the majority of the fixation member 18 and helps keep thefixation member 18 in position. The sheath 200 is then secured to thehandle 180 by an interference fit. The distance that the needle 100extends from the sheath 200 determines the penetration depth of theneedle 100 into the tissue. The delivery device 99 is supplied to thesurgeon with the device 8 preloaded in the needle 100.

Referring to FIG. 5A, an outer protective tube 200 a can be placed overthe sheath 200. The tube 200 a protects the needle tip during shipping.If it is desired to supply the surgeon with a variable length depthstop, the tube 200 a can be provided with gradations 201. The surgeonscores the tube 200 a to provide the tube with the desired length forthe surgical procedure. The tube 200 a is coupled to the handle 180 by aloose interference fit to allow the surgeon to remove the tube 200 a ifthe tube 200 a is not being used during surgery.

Referring to FIG. 5B, to eliminate the need for placement of thedelivery device 99 through an arthroscopy cannula, a removable cannula202 a, formed, for example, of a plastic material, can be placed overthe sheath 200. The cannula 202 a has a distal, tissue penetrating tip203 a and a slot 204 a extending from a proximal end 205 a of thecannula 202 a to within about 0.02 inches of the distal tip 203 a todefine a distal region 206 a. The slot 204 a permits the removal of thecannula 202 a from the delivery device 99 after placement of thedelivery device in the joint. To remove the cannula 202 a, the surgeongrasps the cannula and moves it laterally relative to the sheath 200,until the sheath 200 slides through the slot 204 a. The surgeon thenpulls the cannula 202 a proximally, thus breaking the cannula region 206a and permitting complete removal of the cannula 202 a.

Referring to FIGS. 6-11, in use, preferably under arthroscopic guidance,the user inserts the delivery device 99 into, for example, the kneejoint, and passes the needle 100 through soft tissue 14 and across thetear 12, until the needle tip 108 and the fixation member 16 extendthrough the tissue surface 20. The dimple 130 prevents the fixationmember 16 from sliding proximally in response to forces acting on thefixation member 16 during insertion through tissue 14. The fixationmember 16 is now positioned with the flat, tissue facing surface 154 aof the portion 154 of the fin 152 extending beyond the needle surface106 engaging the tissue surface 20 (FIG. 7). The user then pulls thedelivery device 99 proximally removing the needle 100 from tissue 14(FIG. 8). The force of the engagement of the fixation member 16 with thetissue surface 20 during removal of the needle 100 overcomes theretention force of the crimp 150. The fixation member 16 slides distallyout of the open end 111 of the needle 100 and remains at the surface 20.During the retraction of the needle 100, a portion of suture 10 with theknot 28 is played out of the delivery device 99, with the suture 10extending through soft tissue 14 across the tear 12.

The user then advances the slider 190, advancing the rod 170 to push thefixation member 18 distally, over the dimple 130, to reside in theregion 112 between the dimple 130 and the crimp 150 (FIG. 9). The userthen moves the needle 100 to a spaced location to the side of and exitpoint 229 of suture 10 from tissue 14, and reinserts the needle 100 intosoft tissue 14, across the tear 12, and through the surface 20, untilthe needle tip 108 and the fixation member 18 extend through tissuesurface 20 (FIG. 10). The user then pulls the delivery device 99proximally removing the needle 100 from tissue 14 (FIG. 11). The forceof the engagement of the fixation member 18 with tissue surface 20during removal of the needle 100 overcomes the retention force of thecrimp 150 such that the fixation member 18 slides distally out of theopen end 111 of the needle 100 and remains at surface 20, as describedabove with reference to the fixation member 16.

The free end 30 of suture 10 extends from the sheath 200, as shown inFIG. 11. The user grasps the free end 30 of suture 10 with forceps or byhand and pulls on the free end 30 of suture 10. This shortens the lengthof suture between the fixation members 16 and 18 (at suture portions 10a-10 c), bringing the sides 22, 24 of the tear 12 into juxtaposition, asshown in FIG. 11. When the free end 30 of suture 10 is pulled, the slipknot 28 moves closer to the fixation member 18. Depending on the lengthof suture between the fixation members 16 and 18, the slip knot 28 iseither on the tissue surface 26 or within tissue 14. The slip knot 28allows suture 10 to slide in the direction of arrow 32, but does notallow suture 10 to slide in the opposite direction. The tension placedon suture 10 by pulling on the suture relative to the fixation members16, 18, acts to turn the fixation members such that their long sides 255are in contact with the tissue surface 20. Excess suture 10 can then becut off. Further manipulation of suture 10 is not needed to secure thefixation members 16, 18, although the surgeon may wish to provideadditional fastening as a back-up securement measure.

Referring to FIG. 12, rather than a slip knot 28 acting as a limitingelement allowing suture 10 to be tightened while resisting loosening ofsuture 10, here, a separate limiting element 210 is positioned on thefree end 30 of suture 10. While pulling on the free end 30, the surgeonadvances the limiting element 210 through the tissue 14, in thedirection of arrow 212, until the limiting element 210 is positionedagainst the fixation member 18, as shown in dashed line. This actionacts to close tear 12 and secure the device 8 in place.

The limiting element 210 defines a through bore 216 for receiving suture10. The material of the limiting element 210, for example, acetal, isselected, and the diameter of the through bore 216 is sized relative tosuture 10 to provide the desired amount of friction between suture 10and the limiting element 210 for adequate securement. Thus, the user canslide suture 10 in the direction of arrow 212, but adequate friction isprovided between suture 10 and the limiting element 210 to limit slidingof the limiting element 210 in the opposite direction under normal loadsin the knee joint.

Referring to FIG. 12A, a limiting element 210 a defines two angledchannels 218, 220 for receiving the free end 30 of suture 10. Thelimiting element 210 a has a generally cylindrical surface 221 and ends222, 223. The channel 218 has a first opening 224 at end 222 and asecond opening 225 on the surface 221. The channel 220 has a firstopening 226 at end 223 and a second opening 227 on the same side of thesurface 221 as the channel 218. Suture 10 follows a tortuous paththrough the channel 218, over the surface 221 between the openings 225and 227, and then through the channel 220 with the free end 30 extendingfrom the opening 226. The tortuous path aids in securement of the device8.

In FIG. 12B, instead of the channel openings 224, 225 on the surface 221being on the same side, a limiting element 210 b defines two angledchannels 218 a, 220 a each having a channel end 225 a, 227 a,respectively, on opposite sides of the surface 221. Suture 10 thus wrapspart of the way around the element 210 b to aid in securement of thedevice 8.

Referring to FIG. 12C, rather than positioning the limiting element onsuture 10 after suture 10 exits from the fixation member 18, here, thelimiting element 210, 210 a, or 210 b is positioned along suture 10between the portions of suture 10 passing through the fixation member18.

The limiting elements 210, 210 a, 210 b are slidably received on suture10. In the embodiments of FIGS. 12-12B, the limiting element slides oversuture 10, changing position relative to the fixation member 18, whilein the embodiment of FIG. 12C, suture 10 slides within the limitingelement with the position of the limiting element being relativelyunchanged relative to the fixation member 18.

Referring to FIG. 13, the device 8 can be secured to tissue 14 using alimiting element such as a simple overhand knot 230. The knot 230 isfirst tied in the free end 30 of suture 10 and pushed, in the directionof arrow 240, through tissue 14 and against the fixation member 18, asshown in dashed line. Referring to FIGS. 13A and 13B, the knot 230includes three crossing points, labeled, 230 a, 230 b, and 230 c. Whenunder tension, T, the knot 230 tends to tighten upon itself, rather thanslide in the direction of arrow 240 making it difficult to advance theknot 230 along suture 10. To enable tension, T, to be applied to suture10 at the same time that the knot 230 is advanced in the direction ofarrow 240, a knot pusher 250 is used. The knot pusher 250 is configuredto keep suture at crossing points 230 a, 230 b, and 230 c from touching,such that the knot 230 does not tighten upon itself under tension, T.This permits the knot 230 to slide along the tensioned suture when theknot pusher 250 is advanced in the direction of arrow 240.

The knot pusher 250 has a cylindrical body 252 and an end post 254. Thebody 252 defines a first groove 254 and a second groove 256 on onesurface, and a third groove 258 that is an extension of groove 256 on anopposite surface. The grooves 254 and 256 form an X pattern, and thegrooves 256 and 258 define a loop 260 extending around the body 252. Thethree grooves differ in depth, with the groove 256 being the shallowestand the groove 258 being the deepest. Thus, when suture 10 is formedinto an overhand knot and positioned within the grooves 254, 256, and258, the suture at crossing points 230 a, 230 b, and 230 c does nottouch. Once the knot 230 is advanced against the fixation member 18, theknot pusher 250 is removed by pulling retrograde on the knot pusher. Toaid in removal of the knot pusher 250, a tube (not shown) can beadvanced over the knot pusher 250 between the knot pusher and thesuture. As the tube is advanced past suture crossing point 230 a, thesuture is stripped from the knot pusher 250.

Referring to FIG. 14, one or more additional fixation members 17 with aslip knot 28 formed in suture 10 can be added to the device 8. In use,the fixation members 16 and 18 are implanted as described above, withsuture 10 being tightened to secure the fixation members 16 and 18 inplace. The additional fixation member 17 is then implanted and suture 10tightened to secure the fixation member 17 in place. To accommodate theadditional fixation members, the slot 110 in the needle 100 of thedelivery device 99 is extended. To permit access to the fixation member18 by the push rod 170, the additional fixation members 17 preferablyinclude a through bore (not shown) for passage therethrough by the pushrod 170. The push rod 170 preferably is biased off angle such that whenthe push rod 170 is pulled out of the passage in the fixation member 17,the push rod is no longer aligned with the passage. Subsequentadvancement of the push rod 170 then engages an end face of the fixationmember 17 to push the fixation member 17 toward the tip of the needle100, rather than back through the passage. The slider 190 is preferablyspring loaded such that after the fixation member 18 is pushed out ofthe needle 100, the push rod 170 springs back to engage the nextfixation member 17.

Referring to FIG. 14A, the positions of the fixation members 16 and 18in the needle 100 can be swapped, with the fixation member 18 located inthe distal region 112 such that the fixation member 18 is implanted inthe tissue prior to implantation of the fixation member 16. Referring toFIG. 14B, rather than suture 10 being fixed to the fixation member 16,here suture 10 is attached to the fixation member 16 the same as theattachment to the fixation member 18, such that a second slip knot 28 ais formed and a second free end 30 a of suture extends from the fixationmember 16. To secure the fixation members 16 and 18, both ends 30 and 30a of suture 10 are pulled.

Referring to FIGS. 15A-15C, a wound closure device 1010 includes a firstfixation member, for example, a first retainer 1012, a second fixationmember, for example, a second retainer 1014, and a flexible member, forexample, suture 1016. Suture 1016 connects the first retainer 1012 tothe second retainer 1014. Suture 1016 is tied to the first retainer 1012with a conventional knot, but movably attached to the second retainer1014, allowing a surgeon to shorten the length of suture between theretainers 1012 and 1014, and thereby close a wound. The first retainer1012 has a generally solid cylindrical body 1018 extending axially froma distal surface 1019 a to a flat proximal surface 1019 b. To facilitatepassage of the first retainer 1012 into tissue, both an upper portion1022 a and a lower portion 1022 b of the surface 1019 a are beveledrelative to the axis of the cylindrical body 1018, forming a roundeddistal tip 1022 c. The upper portion 1022 a is beveled at an angle arelative to the axis of the cylindrical body 1018, and the lower portion1022 b is beveled at an angle b relative to the axis.

Attached to the cylindrical body 1018 is a fin-shaped projection 1020that extends from the upper portion 1022 a of the distal surface 1019 ato the proximal surface 1019 b. The fin 1020 defines two horizontallytransverse holes, 1024 a and 1024 b. Suture 1016 is attached to thefirst retainer 1012 by passing the suture through a hole 1024 a in afirst direction (for example, out of the page in FIG. 15A), through ahole 1024 b in a second direction (for example, into the page in FIG.15A), and then forming a conventional knot 1025 near the fin 1020. Theconventional knot 1025 rigidly fixes suture 1016 to the first retainer1012.

The second retainer 1014 has a distal surface 1029 a, a proximal surface1029 b, and a generally cylindrical body 1028 extending axially from thesurface 1029 a to the surface 1029 b. Attached to the body 1028 is anappendage 1026. The appendage 1026 is generally L-shaped incross-section, and extends along an axial length of the body 1028, fromthe surface 1029 a to the surface 1029 b.

The distal surface 1029 a of the second retainer 1014 is beveled in amanner similar to the first retainer 1012: an upper portion 1031 a ofthe surface 1029 a forms an angle q relative to an axis of the body1028, and a lower portion 1031 b of the surface 1029 a forms an angle frelative to the body's axis, forming a rounded distal tip 1031 c. Theproximal surface 1029 b of the second retainer 1014 is flat.

The L-shape of the appendage 1026 is formed by two perpendicularsections: a stem 1036 attached to the cylindrical body 1028 along anaxial length of the body, and a base 1032 attached to the stem. The base1032 defines a vertically transverse hole 1030, and the stem 1036defines two horizontally transverse holes 1034 a and 1034 b. The holes1034 a and 1034 b are perpendicular to the hole 1030, but all threeholes pass through the second retainer 1014 in a direction generallyparallel to the sides 1029 a and 1029 b.

Each of the three holes 1034 a, 1034 b, and 1030 connects the exteriorof the second retainer 1014 to an interior, partially enclosed,protected region 1039. The region 1039 is defined by the base 1032, aninterior surface 1037 of the stem 1036, and a concave groove 1035 withinthe cylindrical body 1028. The groove 1035 extends axially across thebody 1028, along the line where the interior surface 1037 connects tothe body 1028.

Suture 1016 is movably attached to the second retainer 1014 with alimiting element such as a one-way knot 1040. The one-way knot 1040includes a first portion of suture 1016 that forms a loop 1042, and asecond portion of suture that passes around the body 1028 and throughthe loop 1042. The loop 1042 is formed within the protective region 1039defined by the groove 1035, the surface 1037, and the base 1032. Theregion 1039 acts to separate the loop 1042 from tissue when the device1010 is implanted within tissue, preventing the tissue from interferingwith the sliding action of the one-way knot 1040.

To form the one-way knot 1040, suture 1016 is first passed from anexterior of the second retainer 1014, through the hole 1034 a into theregion 1039, and then back out the hole 1034 b to the exterior, formingthe loop 1042 within the region 1039. The suture is then passed over therounded, exterior surface 1041 of the cylindrical body 1028, back intothe region 1039, through the loop 1042, and then to the exterior throughthe hole 1030. Suture 1016 terminates at a free end 1044.

The one-way knot 1040 allows the length of suture between the firstretainer 1012 and the second retainer 1014 to be shortened, but notlengthened. A surgeon can shorten the length of suture between theretainers 1012 and 1014 by pulling on the free end 1044, which drawsadditional suture in the direction of the arrows in FIG. 15A, throughthe holes 1030, 1034 b, and 1034 a, thereby reducing the length ofsuture between the retainers 1012 and 1014. If, however, the surgeonattempts to lengthen the distance between the retainers, for example, bypulling the first retainer 1012 away from the second retainer 1014 (thatis, pulling suture 1016 in the opposite direction of the arrows), thenthe loop 1042 squeezes the portion 1046 of suture 1016 against aninterior compression surface 1043 of the stem 1036, preventing furtherlengthening of the distance between the retainers.

If suture 1016 is a braided suture, as opposed to a smooth suture, thensuture 1016 should be threaded through the second retainer 1014 in aparticular direction. Referring to FIG. 15D, a braided suture 1016 a isformed from numerous threads 1017 a braided from left to right in FIG.15D. Braided suture 1016 a slides more easily if it is pulled in thedirection of braiding (that is, in the direction of arrow S in FIG. 15D)than if it is pulled against the braiding (that is, in the direction ofarrow L in FIG. 15D). Thus, if suture 1016 is a braided suture, thensuture 1016 should be threaded through the second retainer 1014 in thedirection of braiding. If threaded in the direction of braiding, thesuture will slide more easily in the direction of the arrows in FIG.15A, and less easily in the direction opposing the arrows.

The cylindrical portions of the retainers 1012 and 1014 are sized andshaped to fit within a hollow bore of a needle (described below),facilitating arthroscopic implantation of the device 1010. For example,the cylindrical body 1018 has a diameter D1 of about 0.04 inches, andthe cylindrical body 1028 has a diameter D2 approximately equal todiameter D1. The fin-shaped projection 1020 and the L-shaped appendage1026, however, are configured to protrude through a longitudinal slit inthe needle. Delivery of the device 1010 using a hollow needle isdescribed below, with reference to FIGS. 19A-19D and 20A-20D.

The first retainer 1012 has an overall axial length L1 of, for example,about 0.19 inches, and the fin 1020 has a height H1 of, for example,about 0.03 inches. The second retainer 1014 has an overall axial lengthL2 of, for example, about 0.22 inches, a width W2 of, for example, about0.06 inches, and a height H2 of, for example, about 0.07 inches. Angle ais, for example, about 30 degrees, angle b is, for example, about 40degrees, angle q is, for example, about 30 degrees, and angle f is, forexample, about 40 degrees.

The retainers 1012 and 1014 are made from rigid, biocompatiblematerials, such as polyethylene, an acetal, or polypropylene.Alternatively, the retainers 1012 and 1014 can be made from resilientlydeformable materials, as described in Hayhurst, supra, or frombioabsorbable materials. The retainers 1012 and 1014 are preferablyunitary, injection molded pieces, but can also be manufactured by othermethods.

FIG. 16 illustrates the use of the wound closure device 1010 to repair atorn meniscus 1050. The meniscus 1050 has a tear 1052 that unnaturallyseparates distal meniscal tissue 1054 from proximal meniscal tissue1056. A width WM of the meniscus 1050, as measured from points 1060 aand 1060 b to an exterior surface 1058 of the meniscus is, for example,about 0.25 inches.

When the device 1010 is implanted within the meniscus 1050, both theretainers 1012 and 1014 abut the surface 1058, separated by a distanceof, for example, about 1 cm. Suture 1016 passes from the first retainer1012, into distal tissue 1054, across tear 1052, and emerges fromproximal tissue 1056 at point 1060 a. Suture 1016 then passes again intoproximal tissue 1056 at point 1060 b, again traverses tear 1052, andemerges out at surface 1058, where it attaches to the second retainer1014 by means of the one-way knot 1040. From the second retainer 1014,suture 1016 passes again into distal tissue 1054, traverses tear 1052,and emerges from proximal tissue 1056 at or near point 1060 b. The freeend 1044 of suture 1016 emerges from proximal tissue 1056.

Referring to FIGS. 16, 17A, and 17B, once the device 1010 is implanted,a surgeon can close tear 1052 by pulling on the free end 1044 of suture1016. When the surgeon pulls on the free end 1044, four separatemovements occur in succession. First, friction between suture 1016 andthe body 1028 rotates the second retainer 1014 until a lower surface1033 of the base 1032 is flush against meniscal surface 1058, as shownin FIG. 17A. Second, tension in suture 1016 pulls the center of the fin1020 towards surface 1058, causing the first retainer 1012 to alignagainst surface 1058 transversely to the portion of suture 1016 thatexits the first retainer 1012, with both the fin 1020 and the axiallength of the body 1018 pressing against the meniscal surface 1058.Third, continued pulling on the free end 1044 draws additional suturethrough the holes 1030, 1034 b, and 1034 a, by means of the knot 1040,in the direction of the arrows of FIG. 15A, lengthening the free end1044 and shortening the length of suture between the retainers 1012 and1014. Shortening the length of suture between the retainers 1012 and1014 increases the tension in suture 1016 between the retainers, whichpulls distal tissue 1054 and proximal tissue 1056 together, closing tear1052. Since the loop 1042 remains within the protected region 1039 asthe surgeon pulls on the free end 1044, the base 1032 separates the loop1042 from tissue, and suture 1016 does not become wedged between tissueand the second retainer 1014 when the surgeon pulls on the suture's freeend. Once tear 1052 has been closed, the one-way knot 1040 prevents thetwo retainers from pulling apart, and prevents the tear from reopening.

The final successive movement occurs when the surgeon releases the freeend 1044, after closing tear 1052. When the surgeon releases the freeend, the tension in suture 1016 between the two retainers pulls the body1028 of the second retainer 1014 away from the free end 1044, causingthe second retainer 1014 to rotate in the direction of arrow R (FIG.17B), until the body 1028 abuts the meniscal surface 1058, trapping aportion 1062 of suture 1016 between the body 1028 and the surface 1058.(For clarity, suture 1016 is shown spaced slightly from the body 1028and the stem 1036 in FIG. 17B. In actuality, suture 1016 is flushagainst the surfaces of the second retainer 1014 after suture 1016 istensioned by the surgeon.)

When the second retainer 1014 is in its final position, as shown in FIG.17B, suture 1016 is locked in place. The length of suture between theretainers 1012 and 1014 cannot be increased, because the loop 1042 ofthe one-way knot 1040 presses the portion 1046 of the suture against thesurface 1043 of the stem 1036. In addition, the length of suture betweenthe retainers resists being further shortened, since the portion 1062 ofsuture 1016 is wedged between the body 1028 and the surface 1058 of themeniscus.

The wound closure device 1010 is preferably deployed within meniscus1050 arthroscopically, using a hollow needle 1070. Referring to FIG. 18,the hollow needle 1070 defines a bore 1072 and an open distal tip 1074.The diameter DB of the bore 1072 is slightly larger than the diameter D1of the body 1018 of the first retainer 1012, and the diameter D2 of thebody 1028 of the second retainer 1014, allowing the body 1018 and thebody 1028 to fit slidably within the bore. The needle 1070 also includesa longitudinal slit 1076 through a wall of the needle. The slit 1076extends proximally from the open tip 1074, and communicates with thebore 1072. The slit 1076 is sized and shaped to allow the fin 1020 ofthe first retainer 1012 and the L-shaped appendage 1026 of the secondretainer 1014 to protrude from the needle 1070.

The needle 1070 also includes a plunger 1080. The plunger 1080 entersthe bore 1072 through a proximal opening 1082 in the needle 1070, andextends to the proximal surface 1019 b of the first retainer 1012. Theplunger 1080 passes by the second retainer 1014 by sliding along thegroove 1035. When the plunger 1080 is positioned as shown in FIG. 18,sliding the plunger 1080 in the direction of arrow A pushes the firstretainer 1012 distally, but does not move the second retainer 1014.

Prior to surgery, suture 1016 is attached to the retainers 1012 and1014, in the manner described above with reference to FIG. 15A. The tworetainers 1012 and 1014 are then loaded into the bore 1072 of the needle1070. The second retainer 1014 is loaded first, by inserting thecylindrical head 1028 into the bore 1072, through the open tip 1074,such that the appendage 1026 protrudes through the slit 1076. The secondretainer 1014 is pushed proximally into the slit 1076, until the stem1036 abuts a proximal surface 1077 of the slit. Next, the first retainer1012 is loaded into the distal most position in the needle 1070 byinserting the cylindrical body 1018 through the tip 1074, into the bore1072, such that the fin 1020 protrudes through the slit 1076. Both theretainers 1012 and 1014 are loaded with their respective beveled distalsurfaces 1019 a and 1029 a facing the open distal tip 1074.

After the retainers have been loaded, the plunger 1080 is inserted intothe bore 1072 through the proximal opening 1082. The plunger 1080 isslid past the second retainer 1014 along the groove 1035, until a tip1084 of the plunger abuts the proximal surface 1019 b of the firstretainer 1012.

Attachment of suture 1016 to the retainers 1012 and 1014 and loading ofthe retainers and the plunger into the needle 1070 can be performed atthe time of manufacture, that is, pre-loaded, or immediately prior tosurgery.

During surgery (or prior to surgery), the surgeon first pushes theplunger 1080 in the direction of arrow A to separate the retainers 1012and 1014 within the bore 1072. The surgeon pushes the plunger until theretainers are separated by at least a distance L, as shown in FIG. 18,where L is greater than width WM of meniscus 1050. Distance L is, forexample, about 0.35 inches.

Referring to FIGS. 16 and 19A-19D (not to scale), the surgeon nextpushes the needle 1070 through meniscus 1050, in the direction of arrowA, until the fin 1020 of the first retainer 1012 passes entirely throughthe exterior surface 1058 of the meniscus. As the surgeon pushes theneedle 1070 through the tissue, he or she holds the plunger 1080 steady,to prevent the first retainer 1012 from sliding in the direction ofarrow B as the needle is pushed through the meniscal tissue. Since theseparation distance L is greater than the width WM of meniscus 1050, thesecond retainer 1014 does not enter the meniscus at this point in theprocedure.

The surgeon next forces the first retainer 1012 out of the needle 1070through the tip 1074 by pushing the plunger 1080 in the direction ofarrow A, and then seats the retainer 1012 against the surface 1058 ofthe meniscus by pulling on the free end 1044 of suture 1016. Once thefirst retainer 1012 has been seated, the needle 1070 is pulled in thedirection of arrow B, back through meniscus 1050, across tear 1052, andout the hole at the point 1060 a (FIG. 19B).

The surgeon then reinserts the needle 1070 into meniscus 1050 at thepoint 1060 b, and again passes the needle through the meniscus in thedirection of arrow A, across tear 1052, until the tip 1074 passesthrough surface 1058. To eject the second retainer 1014, the surgeonwithdraws the plunger 1080 in the direction of arrow B until the tip1084 of the plunger is proximal to the surface 1029 b of the secondretainer 1014. The surgeon then maneuvers the plunger 1080 until the tip1084 contacts the surface 1029 b, and then pushes the plunger in thedirection of arrow A, forcing the second retainer 1014 through the tip1074. The plunger 1080 and the needle 1070 are then fully withdrawn inthe direction of arrow B, leaving both the retainers 1012 and 1014resting against surface 1058, as shown in FIG. 19D. The surgeon can thentension suture 1016, positioning the retainers against the surface 1058and closing tear 1052, by pulling on the free end 1044, as describedabove with reference to FIG. 16.

Alternative deployment methods are possible. For example, the device1010 can be extracted from the needle 1070 by engaging the fin 1020 withthe surface 1058, rather than by using a plunger 1080. Referring toFIGS. 20A-20D (not to scale), in this embodiment, the plunger 1080 isnot passed through the groove 1035 to the first retainer 1012. Instead,the tip 1084 of the plunger 1080 always remains proximal to the secondretainer 1014.

When the two retainers are loaded into the bore 1072 of the needle 1070,a spacer 1086 is placed between the retainers. The spacer 1086 is asimple cylindrical bar, preferably made from a material that degradesquickly in the body, such as salt. The spacer 1086 has a longitudinallength LS greater than a width WM of meniscus 1050. Length LS is, forexample, about 0.35 inches.

During surgery, the surgeon first pushes the needle 1070 throughmeniscus 1050, in the direction of arrow A, until the fin 1020 passesentirely through the exterior surface 1058 of the meniscus (FIG. 20A).As the surgeon pushes the needle 1070 through the tissue, the surface1077 of the slit 1076 engages the stem 1036 of the second retainer 1014,preventing the two retainers and the spacer from sliding in thedirection of arrow B within the bore 1072. (In addition, the surgeon canhold the plunger 1080 steady to prevent the two retainers from slidingin the direction of arrow B.)

The surgeon next pulls the needle in the direction of arrow B, backthrough meniscus 1050, across tear 1052, and out the hole at point 1060a (FIG. 20B). As the surgeon withdraws the needle, the fin 1020 engagesthe surface 1058, and the first retainer 1012 is pulled out of theneedle 1070, through the tip 1074. As before, the surgeon then seats thefirst retainer 1012 against the surface 1058 by pulling on the free end1044 of suture 1016. Since the spacer 1086 is larger than the width WMof meniscus 1050, the spacer prevents the second retainer 1014 fromentering meniscus 1050, and therefore prevents the second retainer 1014from also being pulled out of the needle 1070 as the needle 1070 ispulled in the direction of arrow B.

Next, the surgeon reinserts the needle 1070 into meniscus 1050 at point1060 b, and again passes the needle through the meniscus in thedirection of arrow A, across tear 1052, until the tip 1074 passesthrough surface 1058. The surgeon then pushes the plunger 1080 in thedirection of arrow A, ejecting both the spacer 1086 and the secondretainer 1014 out of the needle 1070 through the tip 1074 (FIG. 20C).The needle is then fully withdrawn from meniscus 1050, in the directionof arrow B, leaving both the retainers 1012 and 1014 resting against thesurface 1058, as shown in FIG. 20D. The surgeon then pulls on the freeend 1044 to position the retainers and close the tear, as describedabove. The spacer 1086 can either be removed by the surgeon, or leftwithin the body to degrade.

In another alternative deployment method, a modified wound closuredevice is deployed in meniscus 1050 in reverse, with the second retainerbeing deployed first. Referring to FIG. 21 A, a modified wound closuredevice includes a first retainer 1112 that has a beveled face 1119 a,but lacks a fin. The first retainer 1112 has an axial, generallycylindrical body 1118 that defines two transverse holes 1124 a and 1124b. Suture 1016 is attached to the first retainer 1112 by threading thesuture through the hole 1124 a in a first direction, through the hole1124 b in a second direction, and then tying a conventional knot 1125.

Referring to FIGS. 21B-21E (not to scale), in this reverse deploymentembodiment, the second retainer 1014 is positioned distally in the bore1072, with the first retainer 1112 directly proximal. The tip 1084 ofthe plunger 1080 resides immediately proximal to the first retainer 1112in the bore 1072. In operation, the surgeon first pushes the needle 1070through meniscus 1050, in the direction of arrow A, until the tip 1074passes through the surface 1058. The surgeon then pushes the plunger1080 in the direction of arrow A far enough to force the second retainer1014 through the tip 1074, but not far enough to eject the firstretainer 1112.

After the second retainer 1014 has been ejected, the surgeon pulls theneedle in the direction of arrow B, back through meniscus 1050, acrosstear 1052, and out point 1060 a (FIG. 21C). Since the first retainer1112 does not include a fin, it does not protrude through the slit 1076,and does not engage tissue when the needle is pulled in the direction ofarrow B. Next, the surgeon reinserts the needle 1070 into the meniscusat point 1060 b, and again passes the needle through meniscus 1050 inthe direction of arrow A, across tear 1052, until the tip 1074 passesthrough the surface 1058. The surgeon then ejects the first retainer1112 by pushing the plunger 1080 in the direction of arrow A, (FIG.21D), and withdraws the needle 1070 from meniscus 1050. The surgeon thenpositions the retainers and closes the tear 1052 by pulling on the freeend 1044 (FIG. 21E), as described above.

Alternative configurations of the second retainer 1014 and the one-wayknot 1040 are possible.

For example, referring first to FIGS. 22A and 22B, suture 1016 can bethreaded through the second retainer 1014 so that the loop is locatedagainst an exterior surface 1637 of the stem 1036, rather than withinthe region 1039. In this embodiment, suture 1016 is threaded through thesecond retainer 1014 by first passing the suture around the base 1032,into the region 1039, and then out of the region 1039 through the hole1034 a. The suture then passes back into the region 1039 through thehole 1034 b, forming a loop 1642 adjacent the surface 1637. Afterforming the loop, the suture passes through the hole 1030 to theexterior, and then through the loop 1642, terminating at the free end1644.

When the surgeon pulls the free end 1644 of suture 1016, the retainerrotates until the surface 1637 faces the surface 1058 of meniscus 1050(FIGS. 16 and 17A-17B). The cylindrical body 1028 causes part of thesurface 1637 to remain elevated above the surface 1058, creating a smallgap 1639 that contains the loop 1642. The loop 1642, therefore, does notbecome wedged between tissue and the surface 1637 when the surgeon pullsthe free end 1644 to tension the suture.

Referring to FIG. 23, a second retainer 1214 has a structure similar tothe retainer 1014, except that the retainer 1214 lacks a base 1032. Theretainer 1214 includes a cylindrical body 1228 and a stem 1236 thatdefine a wedge-shaped, partially enclosed region 1239 therebetween. Thestem 1236 defines two holes, 1234 a and 1230, and the body 1228 definesone transverse hole 1234 b. Holes 1234 a and 1230 are generallyparallel, and are both generally perpendicular to hole 1234 b. A suture1216 passes from a first retainer (not shown) through hole 1234 a intothe region 1239, and then through hole 1234 b to the exterior of theretainer, forming a loop 1242 within the region 1239. The suture thenwraps around the body 1228 back into the region 1239, through the loop1242, and out of the region 1239 through hole 1230, terminating at thefree end 1244. Alternatively, suture 1216 can wrap around the body 1228two or more times before passing back into the region 1239.

As in the previous embodiments, pulling on the free end 1244 tensionssuture 1216 and shortens the length of suture between the retainers.Pulling on suture 1216 in an opposite direction, however, causes theloop 1242 to press a portion 1246 of the suture against a compressionsurface 1243. Since the loop 1242 is located within the protected region1239, and is therefore spaced from the meniscal surface, the loop 1242does not become wedged between tissue and the retainer when the surgeontensions suture 1216. Unlike the previous embodiments, however, theretainer 1214 does not rotate after the surgeon tensions the suture andreleases the free end 1244.

Referring to FIG. 24, a second retainer 1314 includes a generallycylindrical body 1328 and an offset, generally rectangular appendage1326. The appendage 1326 and the body 1328 define a partially protectedregion 1339. As with the retainer 1014, a front surface 1329 a of theretainer 1314 is beveled.

The appendage 1326 defines three holes, 1330, 1334 a, and 1334 b. Holes1334 a and 1330 are generally straight, while hole 1334 b defines an arcthrough an inside of appendage 1326. A suture 1316 passes from a firstretainer (not shown) through straight hole 1334 a into the region 1339.Suture 1316 then passes out of region 1339 through arc-shaped hole 1334b, forming a loop 1342 within the region 1339. The suture then wrapsaround a comer 1320 of the body 1326, passes through the loop 1342, andthrough hole 1330, terminating at a free end 1344. As with theembodiments of FIGS. 15, 21A-21B, and 22, pulling on the free end 1344shortens the length of suture between the retainers, but pulling onsuture 1316 in an opposite direction causes the loop 1342 to squeeze aportion 1346 of the suture against a compression surface 1343 of theappendage 1326, preventing further movement. Like the embodiment of FIG.22, the retainer 1314 does not rotate after the suture is tensioned andreleased.

Referring to FIG. 25, a second retainer 1414 includes a generallycylindrical body 1428 extending from a beveled distal surface 1429 a toa flat proximal surface 1429 b. A generally rectangular appendage 1426also extends from the surface 1429 a to the surface 1429 b. Therectangular appendage 1426 is attached to the body 1428 along the longside of the rectangle, and is centered along an axial length of the body1428. The body 1428 and the appendage 1426 define a protected region1439.

The appendage 1426 defines two holes, 1434 a and 1430, and the body 1428defines two transverse holes, 1434 b and 1434 c. Hole 1434 b is locatedentirely within the body 1428, but hole 1434 c is located at a juncture1492 between the body 1428 and the appendage 1426. Holes 1434 a and 1430are generally parallel, and are both generally perpendicular to holes1434 b and 1434 c.

A suture 1416 extends from a first retainer (not shown), through hole1434 a into the region 1439, and then out of the region 1439 throughhole 1434 b, forming a loop 1442 within the region 1439. The suture thenpasses back into the region 1439 through hole 1434 c, through the loop1442, and out of the region 1439 through hole 1430, terminating at afree end 1444.

As with the other described second retainer embodiments, pulling on thefree end 1444 tensions suture 1416 and shortens the length of suturebetween the retainers, but pulling on suture 1416 in an oppositedirection causes the loop 1442 to squeeze a portion 1446 of the sutureagainst a compression surface 1443 of the appendage 1426, preventingfurther movement. The region 1439 is separated from the meniscal tissueby the body 1428, preventing the loop 1442 from wedging between theretainer 1414 and tissue when the surgeon pulls on the free end 1444.The retainer 1414 does not rotate after the surgeon tensions andreleases the suture.

Referring to FIG. 26, a second retainer 1514 includes a generallycylindrical body 1528 and an appendage 1526. Both the body 1528 and theappendage 1526 extend from a beveled distal surface 1529 a to a flatproximal surface 1529 b. The appendage 1526 includes a stem 1536attached to the body 1528, and a head 1532 attached to the stem 1536.The stem 1536 is rectangular in cross-section and the head 1532 isD-shaped in cross-section, giving the appendage 1526 a mushroom-shapedcross-section. The stem 1536, the head 1532, and the body 1528 define apartially enclosed, protected region 1539.

The stem 1536 defines two transverse holes 1534 a and 1534 b, and thebody 1528 defines a single transverse hole 1530 located at a juncture1592 between the body 1528 and the stem 1536. A suture 1516 passes froma first retainer (not shown), through hole 1534 a into the protectedregion 1539, and then out of region 1539 through hole 1534 b, forming aloop 1542 within the region 1539. Suture 1516 then passes around theD-shaped head 1532 through a transverse groove 1594 in the head 1532,back into the region 1539, through the loop 1542, and out hole 1530,terminating at a free end 1544. As with the other described embodimentsof the second retainer, pulling on the free end 1544 shortens thedistance between the two retainers, but pulling on suture 1516 in anopposite direction causes the loop 1542 to squeeze a portion 1546 of thesuture against a compression surface 1543 of the stem 1536, preventingfurther movement. Because the loop 1542 is located within the region1539, the loop is prevented from becoming wedged between the retainerand tissue when the surgeon pulls on the free end 1544. The retainer1514, like the retainers 1214, 1314, and 1414, does not rotate after thesurgeon tensions and releases the suture.

Referring to FIGS. 27A-27D and FIGS. 28-30, the second retainer can havea T shape or a crescent shape, and can be deployed at a surface of themeniscus or inter-body. Referring to FIGS. 27A and 27B, a secondretainer 1730 has a T-shape. The base 1732 of the T defines threethrough-holes, 1734 a, 1734 b, and 1734 c, and the stem 1736 of the T isconfigured to penetrate meniscal tissue. The stem 1736 is offset fromthe base 1732 so that the stem does not block hole 1734 b. Referring toFIGS. 27C and 27D, a second retainer 1814 has a flat, generally circularproximal surface 1836, and a rounded distal surface 1838, giving theretainer a generally hemispherical or “crescent” shape. (Alternatively,the surface 1836 can be concave.) The retainer 1814 defines threethrough-holes, 1830, 1834 a, and 1834 b. The holes pass in an axialdirection from the retainer's proximal circular surface 1836 to itsdistal rounded surface 1838.

FIG. 28 illustrates deployment of a device 1810 that has acrescent-shaped second retainer 1814, and a “pulley” retainer 1813. Thepulley retainer 1813 does not act as a dead-end for a suture, nor doesit include a one-way knot. Instead, the pulley retainer 1813 includestwo through-holes, 1824 a and 1824 b. A suture 1816 passes through hole1824 a in a first direction, and then through hole 1824 b in a seconddirection, such that suture 1816 can slide over the pulley retainer 1813in either direction. The pulley retainer 1813 can have the shape andstructure of the retainer 1012 (that is, the holes are located on afin), the simple cylindrical structure of the retainer 1112 of FIG. 21A,or numerous other structures.

In operation, the retainers 1813 and 1814 are deployed using, forexample, a hollow needle 1070, such that the retainer 1814 is positionedon a proximal side of meniscus 1050, and the retainer 1813 is deployedagainst the distal surface 1058. When deployed, suture 1816 passesthrough hole 1834 a of the crescent-shaped retainer 1814 in a generallyproximal direction (arrow P), from rounded surface 1838 to circularsurface 1836, and then through hole 1834 b in a generally distaldirection (arrow D), forming a loop 1842. From the loop 1842, the suturepasses through meniscal tissue, through hole 1824 a of the pulleyretainer 1813, through hole 1824 b of the retainer 1813, and backthrough meniscal tissue to the crescent shaped retainer. The suture thenpasses through the loop 1842, terminating at a free end 1844. Theopposite end 1845 of suture 1816 includes a knob or a knot 1847 thatprevents end 1845 from passing through hole 1834 a. Thus, suture 1816begins at the retainer 1814, in addition to forming the one-way knot atthe retainer 1814.

Referring to FIG. 29, rather than beginning at retainer 1814, the suturecan be affixed to a first retainer 1012. In FIG. 29, a device 1811includes a first retainer 1012 and a crescent-shaped second retainer1814. Suture 1816 passes through holes 1024 a and 1024 b of the retainer1012, forming a knot 1025 as shown in FIG. 15A. From the knot 1025,suture 1816 passes through meniscal tissue and then through holes 1834 aand 1834 b of the retainer 1814, forming a loop 1842. From the loop1842, the suture passes back through meniscal tissue to the firstretainer 1012, and then through a fixed loop 1843 located between theknot 1025 and the first retainer 1012. The suture then passes backthrough meniscal tissue, through hole 1830 of the retainer 1814, andthrough the loop 1842, terminating at the free end 1844.

When a surgeon pulls on the free end 1844 in the device 1811, themechanical advantage is 3:1, since suture 1816 passes between the tworetainers three times. By comparison, in the device 1810, the mechanicaladvantage is 2:1.

Referring to FIG. 30, the crescent shaped retainer 1814 of the device1810 can be deployed inter-body (that is, embedded within meniscaltissue), rather than against a surface of the meniscus. In thisdeployment method, the device 1810 is deployed in the manner describedabove with reference to FIG. 28, or using another deployment method.After positioning the retainers and tensioning the free end 1844,however, the surgeon pushes the retainer 1814 into the meniscal tissue,using, for example, a needle. To facilitate pushing the retainer 1814into the tissue, a point 1817 of the retainer 1814 can be sharp.

Other types of second retainers described herein, whether or not theyinclude a sharp point, can also be positioned inter-body.

In each of the described embodiments of the second retainer, the one-wayknot can be left “loose” until after both the first and second retainersare positioned against the meniscus. In such an embodiment, the suturewould be very long, for example, more than 12 cm long, such that theone-way knot includes considerable slack, and the loop portion of theknot is accessible to the surgeon's fingers. In this embodiment, thesurgeon can position the first and second retainers against the backside1058 by pulling on both the free end and the loop itself. Once theretainers are satisfactorily positioned, the surgeon tightens the knotby pulling on the free end.

The second retainer can employ one-way tightening schemes other than a“one-way knot.” For example, referring to FIG. 31, a device 1650includes the first retainer 1012, a second retainer 1652, and twosutures 1616 and 1654. The second retainer 1652 has a generallycylindrical shape, and defines two through-holes 1656 and 1658. When theretainers 1012 and 1652 are positioned against the backside 1058 ofmeniscus 1050, suture 1616 passes from the first retainer 1012, throughholes 1060 a and 1060 b in the meniscus, and then through holes 1656 and1658 of the retainer 1652, terminating at a free end 1660. Suture 1616does not form a one-way knot at the second retainer 1652. Instead,suture 1616 simply passes through holes 1656 and 1658 in succession,such that the second retainer 1652 acts as a pulley retainer.

The second suture, suture 1654, passes only through hole 1656 of thesecond retainer 1652, and through hole 1060 b of the meniscus. A portion1662 of suture 1654, distal to hole 1656, is thicker than the remainderof suture 1654. This thicker portion 1662 cannot pass through hole 1656.(The thickness of portion 1662 is exaggerated in FIG. 31.)

In operation, a surgeon deploys the two retainers as described abovewith respect to other embodiments, and then pulls on the free end 1660of suture 1616 to position the retainers against the backside 1058 andclose the tear in the meniscus. Once suture 1616 is tensioned to thesurgeon's satisfaction, the surgeon pulls on suture 1654 in the proximaldirection (arrow P), until a segment of the portion 1662 wedges intohole 1656. The portion 1662 wedges suture 1616 in place within hole1656, preventing the length of suture 1616 between the two retainersfrom increasing, and thereby locking the two retainers in place.

Modifications of other portions of the wound closure device 1010 arealso possible. For example, the fin-shaped projection 1020 of the firstretainer need not have the shape shown in the figures. Other types ofprojections capable of protruding through a needle opening and engagingtissue can be used. In addition, as described above with reference toFIG. 20A, the first retainer need not include any projection, but caninstead be a simple cylinder defining holes for affixation of thesuture.

Instead of attaching the suture to the first retainer using aconventional knot 1025, the suture can be welded or glued to theretainer, or can be spliced.

Referring to FIG. 32A, the first retainer need not include an extended,cylindrical body, but can instead have a button-shaped body.Button-shaped first retainer 1712 includes a circular distal side 1719 aand a circular proximal side 1719 b. Two axial holes 1724 a and 1724 bpass from side 1719 a to side 1719 b. A suture 1716 is attached to theretainer 1712 by passing through hole 1724 a in a first direction,through hole 1724 b in a second direction, and then forming aconventional knot 1725 on the distal side of the retainer.

Referring to FIG. 32B, the button-shaped first retainer 1712 is deployedagainst a proximal surface 1796 of meniscus 1050, and the secondretainer 1014 is deployed against the surface 1058. Suture 1716 passesfrom the first retainer 1712 into proximal tissue 1056 at point 1760,such that the knot 1725 is located within the tissue. From point 1760,suture 1716 passes across the tear 1052 to the second retainer 1014,then through the second retainer 1014 in the manner described above withreference to FIG. 15. From the second retainer 1014, the suture passesback into the distal tissue 1054, across the tear 1052, and emerges fromproximal tissue 1056 at point 1760. The suture then terminates at thefree end 1744. As with the embodiments described above, pulling on thefree end 1744 tensions the suture and closes the tear.

Alternatively, the button-shaped retainer 1712 can be deployed on thedistal side of the tear adjacent the second retainer 1014, using themethods described above with reference to FIGS. 16, 19A-19D, 20A-20D,and 21A-21D.

The second retainer need not include a groove 1035 to allow passage of aplunger. Instead, the second retainer can define an axial through-holefor passage of the plunger.

Rather than a suture, the first and second retainers can be connectedwith other types of flexible members.

The wound closure device can include more than two retainers. Forexample, in addition to the first and second retainers, the device caninclude a third retainer identical in structure and function to thesecond retainer. In operation, after deploying the second retaineragainst the surface 1058 of meniscus 1050, the surgeon could again passthe suture across the tear 1052, adding an additional stitch, and thendeploy the third retainer against the surface 1058. After deploying allthree retainers, the surgeon would pull on the free end of the suture,causing the suture to slide over both the second and third retainers,shortening the length of suture between the third and first retainers,and thereby closing the wound.

When more than two retainers are used, one or more of the retainers canbe a pulley, such as the pulley retainer 1813 described above withreference to FIG. 28. For example, the device could include a firstretainer 1012, a pulley retainer 1813, and a second retainer 1014. Thesuture would be affixed to the first retainer, would slide over thepulley retainer, and form a one-way knot at the second retainer.

Referring to FIGS. 33-35, a device 308 for repairing a tear 12 in tissue14 includes a suture 310 attached to a single fixation member 326. Thefixation member 326 defines through holes 330, 332 for receiving suture310. Suture 310 has a first end 312 attached to suture 310 at point 314(as described above with reference to FIG. 2B) to form a looped end 316remote from fixation member 326, and a second, free end 334.

When implanted in the knee joint, the fixation member 326 lies on asurface 20 of tissue 14. The looped end 316 is located in tear 12 andextends along the surface 26 of tissue 14. Suture 310 extends throughtissue 14, passing through the looped end 316 in tear 12, and emergingat the tissue surface 20 where suture 310 loops through the fixationmember 326. Suture 310 extends back through tissue 14, passing throughthe looped end 316 in tear 12 and through a limiting element such as aslip knot 321 formed in suture 310, and emerging at the tissue surface26. As described further below, after the device 308 is positioned intissue 14, the user pulls on the free end 334 of suture 310, in thedirection of arrow 520, to bring the sides 22, 24 of tear 12 togetherinto juxtaposition (as shown in FIG. 33). The slip knot 321 limitsloosening of suture 310. Alternatively, the looped end 316 is located onthe surface 20 between the fixation member 326 and surface 20, as shownin dashed line in FIG. 33.

Referring to FIGS. 36-36B, a delivery device 399 for implanting device308 includes a suture holder 400 and a needle 460. The suture holder 400includes a tube 410 defining a lumen 415 through which the needle 460extends, a shaft 420, and a distal portion 430. The distal portion 430has a first tine 440 defining grooves 445 and 446, and a second tine 450defining grooves 455, 456. The needle 460 has a beveled tip 461 and aslot 462 in a top portion 463 of the needle 460.

When assembled, the fastening member 326 with attached suture 310 ispositioned in the slot 462 with suture 310 preformed with the looped end316 and the slip knot 321. The slip knot 321 is formed as describedabove with reference to FIGS. 2A-2I, though where the fixation member 16is positioned in FIGS. 2A-2I, suture 310 is formed as the looped end 316(FIG. 36C). The looped end 316 is positioned on the suture holder 400within the grooves 445, 446, 455 and 456 of the tines 440, 450 (FIG.36B), and extends along a bottom side 480 of the shaft 420. As shown inFIG. 36, the delivery device 399 includes a handle 451 with a push knob453 for advancing the needle 460 relative to the suture holder 400.

Referring to FIG. 37, in use, the user inserts the distal portion 430 ofthe suture holder 400 into tear 12 of tissue 14, and then advances theneedle 460 through tissue 14, traversing tear 12, and exiting tissue 14at the tissue surface 20. The needle 460 passes between the tines 440and 450, and thus through the looped end 316 of suture 310 (FIG. 38).The user then retracts the needle 460 from tissue 14 (FIG. 39). Thecontact of the fastening member 326 with tissue surface 20 during theretraction of the needle 460 acts to push the fastening member 326 outof the needle 460 such that the fastening member 326 remains at surface20, as described above with reference to FIG. 7. Pulling on the free end334 of suture 310 brings the sides 22, 24 of tear 12 into juxtaposition.The slip knot 321 secures the device 308 in place. Excess suture 310 canthen be cut off.

Referring to FIG. 40, rather than the securing device 308 with a slipknot, suture 310 includes a limiting element in the form of a Chinesetrap or hand cuff 495, that is, an element that when pulled on, tightensaround something disposed within the element. The free end 334 of suture310 is slidably received within the trap 495. When the free end 334 ofsuture 310 is pulled in the direction of arrow 520, the trap 495 isstretched, eventually gripping suture passing therethrough to securesuture 310 and the device 308. The limiting element can also take theform of limiting elements described above with reference to FIGS. 12-12Cand 13.

Referring to FIG. 41, a device 799 for repairing tear 12 in tissue 14includes a fixation member such as a barbed fixation member 800 and asuture 820. Suture 820 has an end 810 attached to the fastening member800. Suture 820 is formed in a loop 830 with a second end 832 of suture820 attached to suture 820. The delivery device 399 (FIG. 36) can beused to deploy the device 799 with suture 820 being tightened to closetear 12 by pushing the fastening member 800 in the direction of arrow840, rather than pulling on a free end of suture. The barbed fixationmember 800 limits loosening of suture 820.

Referring to FIG. 42, an alternative embodiment of a fixation member 600includes through bores 610, 620 with radiused corners 615 to reducefriction between suture 470 and the fixation member 600. Referring toFIG. 43, another embodiment of a fixation member 650, which can be usedin any of the above embodiments, includes a solid rod 660 with ends 680,690, and a braided suture 670 attached to the ends 680, 690. Suture 670forms a loop 700 for receiving suture 10 or suture 310. The loop 700lines up with suture 10, 310 to act as a pulley and reducing frictionbetween the suture and fixation member.

Referring to FIGS. 44 and 45, a surgical device 502 for repairing a tear505 in soft tissue, for example, meniscal tissue 510, includes a firstfixation member 500 and a second fixation member 503 connected by aflexible member such as suture 11 that is tied in a limiting elementsuch as a slip knot 35 such that the distance between the fixationmembers 500, 503 can be shortened but not lengthened. The slip knot 35is moved to shorten the distance between the fixation members 500, 503to appose the two edges 511, 512 of the meniscal tear 505. The slip knot35 of FIG. 44 is positioned between the first fixation member 500 andthe second fixation member 503. Thus, when the surgical device 502 isimplanted, the slip knot 35 is positioned within tissue between thefirst fixation member 500 and the second fixation member 503 (as shownin FIG. 45).

The first fixation member 500 is positioned on an anterior surface 545of the meniscal tissue 510 and the second fixation member 503 ispositioned on a posterior surface 544 of the meniscal tissue 510. Thefree end 115 of the suture 11 extends out of the posterior surface 544and the slip knot is within the meniscal tissue 510. When the slip knot35 is moved to appose the two edges 511, 512, the slip knot 35 remainswithin the meniscal tissue 510.

Referring to FIGS. 46 and 47, the first fixation member 500, the secondfixation member 503, the suture 11, and the slip knot 35 (shown as ablock for simplicity) are delivered to a surgical site in a deliverydevice 517 that includes a handle 520, a needle 525, and a pusher tube530. The needle 525 extends from the handle 520 and includes alongitudinal slot 535 extending along the length of the needle 525except for a proximal portion 534 of the needle. The needle 525 includesa distal end 536 that tapers to a sharp distal point 537. The pushertube 530 is positioned within a lumen 538 of the needle 525 and includesa proximal thumb switch 540 that is positioned outside of the needle 525but is connected to the tube 530 by a connecting plate 541 that passesthrough the slot 535. The pusher tube 530 also includes a distal end 542for contacting and pushing the first fixation member 500. The thumbswitch 540 is used to advance and retract the pusher tube 530. Forexample, the thumb switch is advanced to contact and dislodge the firstfixation member 500 from the needle 525. The needle 525 can be withdrawnfrom the pusher tube 530 such that the pusher tube 530 can functionalone as a knot pusher.

In use, the first fixation member 500 is positioned within the needlelumen 538 in a position adjacent to the distal end 542 of the pushertube 530. The slip knot 35 and the second fixation member 503 arepositioned outside of the needle 525. The suture 11 extends from theslip knot 35 through the slot 535 into the needle lumen 538 and passesproximally through a lumen 543 in the pusher tube 530 and a channel 546in the handle 520.

Referring to FIGS. 48-51, the meniscal tear 505 is repaired in a simpleinsertion and removal operation in which the needle 525 is inserted intoand through the meniscal tissue 510, the first fixation member 500 isdeployed, and the needle 525 is withdrawn. Referring specifically toFIGS. 48 and 49, initially the needle 525 is passed from the posteriorsurface 544 of the meniscus 510 to the anterior surface 545 of themeniscus 510. The suture 11 and the slip knot 35 are pulled into themeniscus 510 with the needle 525 such that the slip knot 35 ispositioned within the meniscal tissue 510. The second fixation member503 remains positioned outside of the meniscus 510 against the posteriorsurface 544. The physician then advances the pusher tube 530 to dislodgethe first fixation member 500 from the needle 525 to a position adjacentto the anterior surface 545 of the meniscus 510. This action furtherpulls the slip knot 35 such that the slip knot remains in the meniscaltissue 510.

Referring to FIG. 50, the physician withdraws the needle 525 from themeniscus 510 leaving the pusher tube 530 within the meniscus 510. Bynext advancing the pusher tube 530 while holding the suture 11 to applytension to the suture 11, the physician uses the pusher tube 530 as aknot pusher to push or advance the slip knot 35 to shorten the length ofthe suture 11 between the first fixation member 500 and the secondfixation member 503, closing the meniscal tear 505. Using the pushertube 530 as a knot pusher aids the physician in seating the knot 35 deepwithin the tissue. Referring to FIG. 51, the physician next withdrawsthe pusher tube 530 from the meniscus 510 and, to complete the repair,cuts the suture 11 adjacent to the posterior surface 544 of the meniscus510. If necessary, the physician inserts additional fixation members 500and 503 to further repair the tear.

Referring to FIG. 52, in another implementation, an atraumatic device550 for delivering the surgical device 502 has a needle 525 a with acurved distal end 555 rather than the tapered distal end 536 of theneedle 525. The needle 525 a also has a slot 535 a. The curved deliverydevice 550 is used to deliver the first fixation member 500, the secondfixation member 503, the suture 11, and the slip knot 35. The curveddistal end 555 is used to avoid neuromuscular tissue, for example, inthe knee joint when inserting the needle 525 a. The curved deliverydevice 550 is loaded with the fixation members 500, 503, the suture 11,and the slip knot 35 in a different manner than the delivery device 517.In particular, while the second fixation member 503 remains positionedexternal to the needle 525 a, the slip knot 35 is placed within theneedle 525 a and the suture 11 extends from the slip knot 35 through theslot 535 a to the second fixation member 503 and back through the slot535 a to the slip knot 35 and proximally through the pusher tube 530.Positioning the slip knot 35 within the needle 525 a advantageouslyreduces the profile of the device 550 and also protects the slip knot 35from contacting any surfaces that could possibly damage the slip knot35. The slip knot 35 and the first fixation member 500 are separated bythe block 158, having features described above.

If there is no block 158 positioned between the first fixation member500 and the slip knot 35, the physician can accidentally dislodge theslip knot 35 prematurely if he or she pushes the pusher tube 530 too fardistally. By including the block 158 to separate the first fixationmember 500 and the slip knot 35, the physician has more distance that heor she can push the pusher tube 530 forward without accidentallydislodging the slip knot with the first fixation member 500. When thepusher tube 530 is advanced to an extended position, the block 158 ispushed out of the needle 525 with the first fixation member 500. Becausethe block 158 is bioabsorbable, it will be absorbed and thereby notremain adjacent to the tissue as a long-term irritant.

The delivery device 555 is used to deliver the first fixation member500, the second fixation member 503, the slip knot 35, and the suture 11in the same manner as the delivery device 517. A primary difference inthe manner of delivery is the ability to direct the curved distal end555 around neuromuscular tissue. Although the slip knot 35 is deliveredwithin the needle 525, this does not affect the manner in which thephysician delivers the first fixation member 500 or the second fixationmember 503. Although shown having a curved distal end 555, the needle525 a also will function with a straight end.

Referring to FIG. 53, as an alternative to the block 158, a deliverydevice 550 a includes a pusher tube 570 having a narrow distal section575 and a wider middle section 580. Like the block 158 described abovewith respect to FIG. 52, the narrow distal section 575 is used toincrease the distance that the physician can advance the pusher tubewithout accidentally dislodging the slip knot 35. The slip knot 35 ispositioned on the narrow distal section 575 at a position adjacent tothe wider middle section 580. In use, the physician advances the pushertube 570 to push the first fixation member 500 out of the needle 525. Byadvancing the pusher tube 570 further, the middle section 580 aids inpushing the slip knot 35 out of the needle 525 a. Although the slip knot35 will be pulled out by merely retracting the needle 525 after placingthe first fixation member 500, the middle section 580 provides thephysician extra control in placing the slip knot. Moreover, the middlesection 580 functions as a knot pusher to push or advance the slip knot35 deeper into the meniscal tissue. Otherwise, the first fixation member500, the second fixation member 503, and the slip knot 35 are deliveredin the same manner as described above. Namely, the needle 525 a isinserted through the meniscus 510 and the meniscal tear 505, the pushertube 570 is advanced to an extended position to place the first fixationmember 500 against the anterior surface 545 of the meniscus 510, therebyadvancing the wider section 580. Finally, the needle 525 a is withdrawn,which leaves the slip knot 35 in the meniscal tissue 510 and the secondfixation member 503 positioned against the posterior surface 544 of themeniscus 510. The pusher tube 570 then is advanced to use the widersection 580 as a knot pusher to push the slip knot 35 to shorten thelength of suture 11 between the first fixation member 500 and the secondfixation member 503, which apposes the edges of the tear 505. The pushertube 570 then is withdrawn and the suture 11 is cut proximally to theslip knot 35.

Referring to FIG. 54, a surgical device 2000 includes a first fixationmember 2005, a second fixation member 2010, and a flexible member, suchas a suture 2015. The suture 2015 couples the first fixation member 2005and the second fixation member 2010, and has a knot 2020 formed at eachend 2025 of the suture 2015 to prevent the respective fixation memberfrom being separated from the suture 2015. The first fixation member2005 includes a longitudinal channel 2030 and a fin 2035. Thelongitudinal channel 2030 is open to a side 2033 of the fixation member.As described in more detail below, the fin 2035 is used to catch tissueto release the first fixation member 2005 from a delivery device whenthe delivery device is withdrawn from a tissue site during a surgicalprocedure. The second fixation member 2010 includes a longitudinalchannel 2040 that opens to a side 2045. As described in more detailbelow, the openings to the sides 2033, 2045 allow the first fixationmember 2005, the second fixation member 2010, and the suture 2015 to beplaced under tension and cause the retainers to shift relative to thesuture to be aligned generally perpendicularly to the suture. In thismanner, the fixation members 2005, 2010 resist pullback through tissue.

Referring also to FIG. 55, the surgical device 2000 is delivered intotissue, such as meniscal tissue, using a delivery device 2050 thatincludes a needle 2055, a handle 2060, and a thumb-activated pusher rod2065. The needle 2055 includes a longitudinal slot 2070 through whichthe fin 2035 extends. The thumb-activated pusher rod 2065 can be used tomaintain the position of the fixation members 2005, 2010 within theneedle 2055 during delivery and to assist in delivering the secondfixation member 2010.

Referring to FIGS. 56-58, the surgical device 2000 and delivery device2050 are used to repair a meniscal tear 2075. The knee joint is accessedanteriorly and the needle is inserted into an anterior portion 2085 ofthe meniscus 2080 through a first insertion point 2087 and pushedthrough the meniscus to a posterior portion 2090 of the meniscus 2080such that the first fixation member 2005 extends from the meniscus at afirst exit point 2092. While pushing the needle through the meniscus,the physician optionally can apply a force to the thumb-activated fingerswitch 2067 (which is integral with the pusher rod 2065) to preventtissue from pressing the fin 2035 further back into the needle. Ofcourse, the longitudinal slot 2070 can be fabricated to a length that isslightly longer than the length of the fin 2035 to provide an automaticlimitation on the retrograde movement of the first fixation member 2005.

The physician next pulls back on the delivery device 2050 and pulls theneedle 2055 out of the meniscus 2080, although not out of the kneejoint. The physician then moves the needle 2055 to a second insertionpoint 2093 adjacent to the first insertion point 2087. The physicianthen inserts the needle 2055 a second time into the meniscus 2080 fromthe anterior portion 2085 of the meniscus through the second insertionpoint 2093 and pushes the needle through the meniscus to the posteriorportion 2090 of the meniscus such that the second fixation member 2010extends from the opposite side of the meniscal tear 2075 at a secondexit point 2094. A length 2096 of suture 2015 spans the meniscus betweenthe first insertion point 2087 and the second insertion point 2093. Thephysician next uses the thumb-activated pusher rod 2065 to dislodge thesecond fixation member 2010 from the needle 2055.

Proper placement of the second fixation member 2010 relative to thefirst fixation member 2005 will cause the suture 2015 to be in tension.Proper placement is ensured by setting the second insertion point 2093far enough from the first insertion point 2087 such that there is littleplay in the suture prior to placing the second fixation member 2010. Asnoted above, the fixation members 2005, 2010 are placed such that thereis tension in the suture. To relieve some of the tension, the fixationmembers 2005, 2010 will shift position to be generally perpendicular tothe suture 2015. This advantageously limits the likelihood that thefixation members 2005, 2010 will be pulled back into the channelscreated by the needle during insertion. The tension in the suture 2015also advantageously apposes the edges of the meniscal tear 2075 to healthe tear.

Referring to FIG. 59, the surgical device 2000 also can be implanted ina different position relative to the tear than illustrated in FIGS.56-58. For example, instead of placing the fixation members 2005, 2010on opposite sides of the meniscal tear 2075, the fixation members 2005,2010 can be placed on the same side of the tear and the suture 2015 usedto appose the edges of the tear. In this positioning of the fixationmembers 2005, 2010, the needle 2055 is advanced anteriorly to distallythrough the meniscal tear 2075, the first fixation member 2005 placed,and the needle 2055 withdrawn. The physician next moves the needle 2055laterally to create a length 2097 of suture that extends along theanterior surface 2085 of the meniscus. The needle 2055 then is advancedanteriorly to distally through the meniscal tear 2075, the pusher rod2065 advanced to dislodge the second fixation member 2010, and theneedle withdrawn. Again, the tension in the suture 2015 causes thefixation members 2005, 2010 to shift to be perpendicular to the suture.The tension in the suture tends to pull the fixation members 2005, 2010in the direction of the length 2095 of suture that extends along themeniscus, which apposes the edges of the meniscal tear.

Depending on the size of the tissue wound, three or more fixationmembers can be used in the devices discussed above. The additionalfixation members can be pulley retainers, can be similar to the secondfixation member, or can be both additional pulleys and additional secondretainers.

The wound closure and repair devices discussed above need not bedeployed using a needle, and need not be deployed arthroscopically.Instead, a surgeon can place the fixation members against the tissueduring an open procedure.

The wound closure and repair devices discussed above can be used torepair tissue wounds other than meniscal tears. For example, the devicescan be used to repair tears in skin, muscles, and ligaments, and tore-attach tissue to support structures, such as bones.

Referring to FIGS. 60 and 61, a surgical device 618 is used forreattaching soft tissue, for example, tendon, ligament, or cartilage 9,that is torn partially or completely from a bone 15, to the bone 15,includes a fixation member such as a fastener 21, a fixation member suchas a retainer 25, and a flexible member, such as a suture 11. The suture11 couples the fastener 21 and the retainer 25, and is tied in alimiting element such as a slip knot 35 such that the distance betweenthe fastener 21 and the retainer 25 can be shortened by pulling on afree end 115 of the suture 11. The retainer 25 is positioned between theslip knot 35 and the fastener 21 such that, when the surgical device 618is implanted, the slip knot 35 is positioned against the retainer 25, asillustrated in FIG. 60.

Referring to FIG. 62, a surgical assembly 5 includes the surgical device618 and a delivery device 299. The delivery device 299 includes a handle105 and a cannula 103, and is configured to receive the fastener 21, theretainer 25, and the suture 11. The suture 11 passes through the cannula103 and the handle 105. The handle 105 includes a circumferential slot296, a longitudinal slot 107, and a connecting member 108 that connectsthe handle 105 to the cannula 103. When the fastener 21, the retainer25, and the suture 11 are received in the cannula 103, the suture 11 ispassed out of the handle 105. To ensure that the fastener 21 and theretainer 25 remain within the cannula 103 prior to use, the physicianpulls the suture 11 through the longitudinal slot 107 until the suture11 is within the circumferential slot 296 and then wraps the suture 11around the connecting member 108. In this manner, the fastener 21 andthe retainer 25 cannot be withdrawn from the cannula 103 without firstloosening the suture 11 from the connecting member 108.

Referring to FIG. 63, the suture 11 is tied in a slip knot 35 or othertype of movable attachment or knot. The movable attachment of the suture11 to the retainer 25 is one-way such that the length of the suture 11between the fastener 21 and the retainer 25 can be shortened, but notlengthened. The slip knot 35 is formed, for example, by using the suture11 to make one or more loops 292 around itself and then tightening theloops 292 against the segment of suture 11 that they encircle. Asillustrated in FIGS. 62 and 63, the suture 11 extends from the slip knot35, through the retainer 25, through the fastener 21, back through theretainer 25, and through the slip knot 35. If the fastener 21 is in afixed position, such as within bone 15, pulling the free end 115 of thesuture 11 in a first direction A pulls the slip knot 35 along the suture11 in a generally opposite direction B, which is in the direction of thefastener 21. As long as the free end 115 is pulled, the slip knot 35will continue to slide along the suture 11 in the direction B until theslip knot's movement is obstructed by the retainer 25. In oneapplication of the surgical device 618, the slip knot's movement isobstructed by the retainer 25 when soft tissue 9 is compressed betweenthe retainer 25 and the fastener 21.

As shown in FIG. 60, the surgical assembly 5 is generally used, forexample, to reattach tissue torn from bone, by placing the fastener 21through the tissue and into bone, and then tightening the slip knot 35to push the retainer 25 against the torn tissue. In this manner, thetissue is forced against the bone and the torn edge of the tissue may beplaced in apposition to promote healing and prevent further trauma tothe tissue.

Referring to FIGS. 64 and 65, the fastener 21 is, for example, a screwincluding a head 135 and a shank 291 with threads 145. The head 135 isshaped to mate with the cannula 103. For example, the outer surface 146of the head 135 has a hexagonal shape and the cannula 103 has ahexagonally shaped opening 155 (FIG. 67) that receives the head 135. Thehead 135 is separated from the shank 291 by a ridge 147 for purposesdiscussed below. The head 135 includes one or more openings 290 throughwhich one or more sutures 11 pass. Generally, only one suture will beused and therefore only one of the openings 290 will include a suture 11passing through it. Nonetheless, one or more sutures 11 can be passedthrough each opening 290 and couple to one or more retainers 25. Thethreads 145 are of any configuration, such as a set of parallel threadsof different pitch, angle, and/or diameter.

The fastener 21 can be made of a biocompatible metal, polymer, orbioabsorbable polymer, such as titanium, stainless steel, polyethylene,polypropylene, polyglycolic acid, or polylactic acid. The can be made byone or more of many methods, including, for example, machining, molding,casting, or cutting. Alternatively, the fastener 21 can be a push-intype fixation member such as described in the Hayhurst patent, supra.

Referring also to FIGS. 66-68, the hexagonal opening 155 for receivingthe screw head 135 is at the distal end 156 of a lumen or longitudinalchannel 157 having a hexagonally shaped bore 159 that extends betweenthe hexagonal opening 155 and a proximal hexagonal opening 297 of thecannula 103. The lumen 157 extends from the cannula 103 through thehandle 105 and terminates at an opening 161. The suture 11, the slipknot 35, the retainer 25, and the head 135 of the fastener 21 are placedwithin the cannula lumen 157 with the slip knot 35 placed proximal tothe retainer 25 and the head 135 of the fastener 21 placed distal to theretainer 25. The threaded shank 291 of the fastener 21, however, is notpositioned within the cannula lumen 157 but instead extends beyond thecannula 103. The free end 115 of the suture 11 passes out of theproximal opening 161 in the handle 105 such that the physician can graspthe suture 11 and gently pull on the suture 11 to apply tension to thesuture 11. Pulling on the suture 11 applies tension to the suture 11because the ridge 147 prevents the physician from pulling the fastener21 further into the lumen 157. By applying tension to the suture 11, thephysician ensures that the fastener 21 will not accidentally fall out ofthe lumen 157 during delivery of the surgical device.

When the suture 11, the slip knot 35, the retainer 25, and the head 135are positioned in the lumen 157, the retainer 25 and the fastener 21 areseparated by a tube or block 358 of a rapid absorbing material, such asthrombin, a dry salt, or dry saline. The tube 358 provides a separationbetween the fastener 21 and the retainer 25 such that the fastener 21can be delivered without the retainer 25 accidentally being removed orotherwise dislodged from the cannula lumen 157 with the fastener. If theseparation between the fastener 21 and the retainer 25 is notsufficient, when the physician delivers the fastener 21 the retainer 25may be dislodged from the lumen 157. The tube 358 also can be used as adrug or therapeutic agent delivery device to provide a drug ortherapeutic agent to the surgical site. For example, the tube 358includes a wound healing agent, an anti-bacterial agent, or ananti-inflammatory agent. The tube 358 is expelled from the cannula 103when the retainer 25 is advanced forward in the cannula 103, asdescribed below.

The suture 11 is made of any suture material, such as, for example,polyethylene or polypropylene. The handle 105 and the cannula 103likewise are made of a biocompatible polymer such as, for example,polyethylene or polypropylene, or a biocompatible metal, or acombination of these.

Although the absorbable tube 358 is described as being pulled from theneedle and/or cannula by the tension in the suture as the suture pullson the adjacent retainer or screw, the absorbable tube can include abarb or other protrusion to actively catch onto tissue and fix theposition of the tube 358 when the cannula or needle is withdrawn.

As illustrated in FIGS. 69-73, the retainer 25 includes one or morechannels or openings 162, sides 163, an upper surface 165, and a lowersurface 174. The channels or openings 162 receive the suture 11 andtherefore are smooth or tapered to limit any sharp edges that coulddamage the suture. The sides 163 and the upper surface 165 likewise aresmooth to provide atraumatic tissue contacting surfaces. Passing betweenthe channels 162 on the upper surface 165 is a groove 166 such that whenthe slip knot 35 is tightened the suture 11 is recessed in the groove166. In this manner, less of the suture 11 is exposed to mechanicalforces associated with body movement. The lower surface 174 preferablyincludes one or more longitudinally-oriented protrusions 175 thatcontact the tissue being reattached when the retainer 25 is implanted.The protrusions 175 provide traction against the tissue to limitmovement of the retainer 25 relative to the tissue.

The retainer 25 has a low profile to limit protrusion from the softtissue 9 so that the retainer 25 does not extend from the soft tissuesurface, for example, to avoid impingement against other tissuesurfaces. For example, if the low profile retainer 25 is used to repairthe rotator cuff, the thickness of the retainer 25 is selected toprevent impingement of the retainer 25 against the bony surface of theaccromium. Other considerations that can be used in determining thethickness of the retainer 25 include (1) the strength of the retainerrelative to the suture passing through the retainer, (2) the depth intothe soft tissue that the retainer is seated, and (3) the cosmeticappearance caused by protrusion against the skin (for example, repair ofthe lateral collateral ligament). In general, the low profile retainerhas dimensions that prevent protrusion of the retainer beyond the tissuein which it is placed. Although some protrusion beyond the overallsurface of the soft tissue is satisfactory, if the low profile retaineris positioned flush with the overall surface of the soft tissue (forexample, by tightening the slip knot against the retainer to bury theretainer into the soft tissue) there is a reduced likelihood ofimpingement and/or contact with other tissue surfaces.

With respect to determining the thickness of the retainer 25 based onthe strength of the suture, the thickness can be determined such thatthe retainer 25 has the same approximate strength as the suture. Theprinciple behind this consideration is that the retainer 25 does notinherently need to have an increased thickness and, as such, one guideto determining thickness is to provide the minimum thickness necessaryto have a similar strength as the suture. In this manner, the retainer25 provides adequate strength without protruding too much. With respectto the cosmetic appearance caused by the retainer 25, if the retainer isimplanted close to the skin surface, a relatively thin retainer wouldprotrude less from the skin than a relatively thick retainer. As such,the recipient of the retainer is less likely to notice the retainer orto find the retainer to be a source of irritation.

For example, in one implementation, the retainer 25 has a thickness, t,of between approximately 0.5 and 2.5 mm and, preferably, approximately 2mm. The length, 1, of the retainer 25 is between approximately 6 mm and10 mm and, preferably, approximately 8 mm. The width, w, of the retainer25 is between approximately 1.5 and 3 mm and, preferably, betweenapproximately 2 mm and 2.5 mm.

Referring to FIGS. 74-76, in an alternative implementation, a retainer25 a is a low profile implant that has a lower surface 174 a withtransverse protrusions 175 a. The protrusions 175 a provide tractionagainst a tissue to limit movement of the retainer 25 a relative to thetissue. The retainer 25 a has two channels 162 a extending between agenerally smooth upper surface 165 a and the lower surface 174 a. Thechannels 162 a are oppositely oriented at an angle, α, to surfaces 165a, 174 a. The angle, a, is between about 30° and 60°. By angling thechannels 162 a, the force vector associated with the sutures 11 passingthrough the channels 162 a is optimized to achieve optimal repairstability when used with the slip knot 35. In particular, by angling thechannels 162 a, the slip knot 35 has a reduced likelihood of looseningbecause the suture 11 on the upper surface 165 a is under tension in adifferent direction than that of the suture 11 that passes through thechannels 162 a. Angling the channels 162 a also beneficially causes thetwo lengths of suture 11 that pass from the retainer 25 a to thefastener 21 to be adjacent to each other. By keeping the two lengths ofsuture 11 adjacent to each other, the channel through the soft tissuethrough which the suture 11 passes is smaller than it would be if thetwo lengths of suture were spread apart. Finally, the channels 162 ahave a tapered opening 176 to accommodate suture 11 passing through theopenings 162 a and resting against the smooth upper surface 165 a. Thetapered openings 176 limit damage to the suture 11 that can be caused bysharp edges.

Referring to FIGS. 77-80, less oblong shaped retainers 25 b, 25 c, 25 d,and 25 e include an upper surface 165 b, 165 c, 165 d, 165 e, a lowersurface 174 b, 174 c, 174 d, 174 e, and channels 162 b, 162 c, 162 d,162 e, respectively, through the retainer 25 b, 25 c, 25 d, 25 e.Referring to FIG. 77, the lower surface 174 b and/or the upper surface165 b are smooth. Referring to FIG. 78, the lower surface 174 c hasprotrusions in the form of dimples 188. Referring to FIG. 79, the lowersurface 174 d has protrusions in the form of ridges 189. Referring toFIG. 80, the lower surface 174 e has protrusions in the form of ridges189 and teeth 190. The channels 162 b, 162 c, 162 d, and 162 e areangled relative to the surface 174 and also have a tapered or flaredopening as described with respect to FIGS. 74-76.

The retainers 25 and 25 a-e are made of a bioabsorbable material, abiocompatible plastic, or a biocompatible metal and are made using anywell-known technique, including, for example, injection molding,casting, machining, cutting, and stamping. They can be coated with atherapeutic material that, for example, promotes healing of torn tissueand/or prevents infections.

Referring again to FIG. 68, the delivery device 299 is loaded with thesuture 11, the retainer 25, and the fastener 21 in the opposite order inwhich these items are deployed. The tube or block 358 is optionallyinserted between the retainer 25 and the fastener 21. The free, proximalend 115 of the suture 11 is inserted into the open, distal end 156 ofthe cannula 103 and threaded through the lumen 157 until the free,proximal end 115 extends through the proximal opening 161 of the handle105. The slip knot 35 followed by the retainer 25 is manipulated intothe lumen 157 while gently pulling the proximal end of the suture 11.The tube 358 is then inserted into the lumen 157. In the last step, thehead 135 is positioned within the bore 159 of the lumen 157 until theridge 147 is pressed against the distal end 156 of the cannula 103. Theproximal end 115 of the suture 11 is then given a final gentle pull toensure that the fastener 21 is securely positioned within the lumen 157.

Referring to FIG. 81, the surgical assembly 5 is used in an arthroscopicprocedure with an arthroscope 19 to repair, for example, a rotator cuffinjury. In this procedure, two small incisions are made into theshoulder joint and the arthroscope 19 is inserted through one incisionand the delivery device 299 is inserted through the second incision. Thedelivery device 299 optionally is placed through a cannula in the secondincision. The arthroscope 19 provides a video means of viewing theinside of the shoulder joint throughout the procedure. Prior toinserting the delivery device 299, the physician initially removes anyunhealthy or degenerated rotator cuff tissue. Then, the physicianprepares the area of the humerus bone 15 where the tendon 9 tore awayfrom the bone 15. For example, the physician gently roughens the bone'scortex to enhance healing by decorticating the cortical surface of thebone to prepare a fresh bed or bleeding surface to encourage tissue toheal. The decortication of the bone results in a slight trough, known asa decorticated trough, to which the tendon is attached.

Following the initial preparatory work, the physician passes thedelivery device 299 through the tendon tissue 9 until the fastener 21 isin contact with the bone 15. The physician then screws the fastener 21into the bone 15 by grasping the handle 105 and rotating it. Thefastener 21 has either left-handed or right-handed threads and thephysician rotates the handle in the appropriate direction based on thethreads to insert the fastener 21 into the bone 15. Because the cannula103 has the hexagonal bore 159 and the fastener 21 has the hexagonalhead 135, rotating the handle transfers the rotational force to the head135 and fastener 21 and thereby screws the fastener 21 into the bonetissue.

As illustrated in FIG. 82, the physician then withdraws the deliverydevice 299 from the tendon 9. Because the fastener 21 is inserted intothe bone 15, withdrawing the delivery device 299 pulls the suture 11,the slip knot 35, and the retainer 25 out of the lumen 157. If thephysician has inserted the tube 358 into the cannula 103, the tube 358is also pulled out of the cannula 103 when the retainer 25 is pulledout.

Referring to FIG. 83, the physician then threads the free end 115 of thesuture 11 through a knot pusher 192, advances the knot pusher 192 overthe suture 11 to slip knot 35, and, while pulling the free end 115,pushes the slip knot 35 against the retainer 25, and presses theretainer 25 and the slip knot 35 against the tendon tissue 9 to firmlyposition the tendon 9 against the bone 15. The knot pusher can be, forexample, the knot pusher component of the Smith & Nephew FasT-FixMeniscal Repair System (Smith & Nephew, Andover, Mass.).

Referring to FIG. 84, the physician then cuts the suture 11 at aposition adjacent to the slip knot 35. After examining the repairthrough the arthroscope, the physician determines whether additionaltissue repair is necessary and, if so, places one or more additionalfasteners 21 and retainers 25.

Referring to FIGS. 85-89, in another implementation, a surgical assembly261 includes a delivery device 267 and a surgical device 205. Thesurgical device 205 includes the fastener 21, the suture 11, and theslip knot 35 of FIG. 60, and, rather than a single retainer, a pair oflow-profile retainers 208 a, 208 b. One or more absorbable tubes 358 arebetween the retainers 208 a and 208 b, and between the distal retainer208 a and the fastener 21. The delivery device 267 and the surgicaldevice 205 are used in procedures in which there is, for example,insufficient tissue to grasp or poor quality tissue such that a singlefastener 21 and retainer 25 would not adequately reattach the tissue 9to the bone 15. As described in more detail below, using the surgicaldevice 205 allows the physician to bridge a gap between an area of pooror insufficient tissue and an area of better quality tissue and pull thebetter quality tissue in the direction of the fastener 21 to attach thebetter quality tissue to the bone 15. For example, there may beinsufficient tissue to grasp when the patient's shoulder is in abductionand there is not sufficient space to manipulate the delivery device 267to deliver the retainers 208 a, 208 b through the tissue. There also maybe poor quality tissue and insufficient tissue to grasp when the tearhas a frayed end that must be trimmed. There may be poor quality tissuewhen the patient is elderly and the tissue has degenerated. In thesesituations, the surgical device 205 is used to bridge the gap betweenthe better quality tissue and the bone to which the tissue is to beattached. The pair of retainers 208 a, 208 b also beneficially helps todistribute the load on the suture 11.

The delivery device 267 includes a handle 210, a cannula 215, and aretractable needle 263. The needle 263 includes a thumb pad 211 at theproximal end 269 of the needle 263 and a sharpened tip 233 at the distalend 271 of the needle 263. The thumb pad 211 protrudes out of an openregion 231 in the handle 210 to provide access to the thumb pad 211 forthe surgeon to advance or retract the needle 263. The open region 231 isconfigured to be slightly wider than the thumb pad 211 such that thethumb pad 211 will slide within the open region 231 with minimal lateralplay. The open region 231 has a length, 1, that provides sufficient playfor the needle 263 to be fully extended by moving the thumb pad 211 inone direction, arrow A, and completely retracted by moving the thumb padin the opposite direction, arrow B.

The needle 263 includes a longitudinal slot 235 that opens into achannel 213 defined within the needle 263. The needle 263 slides withina lumen 245 of the cannula 215 and can be advanced to extend distallyfrom the cannula 215 or can be retracted to be wholly contained withinthe cannula 215. As described in more detail below, the retainers 208 a,208 b are positioned within the channel 213 because to deliver theretainer 208 a, the needle 263 is extended to pass through the softtissue. Like the needle 263, the cannula 215 includes a slot 241 thatopens into the lumen 245. The physician positions the suture 11 suchthat it passes through the slots 241, 235 rather than passing over thesharpened tip 233 of the needle 263, thereby preventing the sharpenedtip 233 from damaging the suture 125 (FIG. 93). As described in moredetail below, the purpose of the needle 263 is to create an opening topass the cannula 215 through the tissue 9 to place the retainers 208 a,208 b. Because the suture 11 is passed through the slots 241, 235, thesuture 11 will not pass over the sharpened tip 233 and thereby be cut bythe sharpened tip 233 when pressing the sharpened tip 233 against thetissue 9 to create the opening with the needle 263. Thus, one purpose ofthe slots 235, 241 is to provide a location in which to pass the suture11 such that the suture 11 is away from the sharpened tip 233.

The retainers 208 a, 208 b each include a barb or protrusion 217 thatextends from a surface 251 of the retainer 208 a, 208 b and passesthrough the slots 235, 241. As described in more detail below, the barb217 catches on the tissue 9 when the delivery device 267 is beingwithdrawn. By catching the tissue 9, the barb 217 acts to withdraw theretainer 208 a from the needle 263 and cannula 215.

As illustrated in FIG. 90, the delivery device 267 is used to reattachsoft tissue to bone in, for example, the rotator cuff. Initially, thesurgical site is prepared as described above, including the physicianforming a decorticated trough 253. The physician then passes the cannula215 and the fastener 21 through the tendon tissue 9 until the fastener21 is in contact with the bone 15. In the same manner as describedabove, the physician inserts the fastener 21 into the bone 15 bygrasping and rotating the handle 210. In particular, because the lumen245 of the cannula 215 is shaped, for example, to have a hexagonalshape, and the fastener 21 has the mating hexagonal head 135, asdescribed above with respect to FIGS. 66-68, rotating the handletransfers the rotational force to the head 135 and the fastener 21 andthereby screws the fastener 21 into the bone tissue 15. FIG. 90illustrates a situation in which there is an insufficient amount oftendon tissue 9 that is accessible by the physician, and the physicianhas inserted the fastener 21 through the tendon tissue 9 into thedecorticated trough 253 approximately where he or she wants to reattachthe tendon tissue 9. As described below, subsequent placement of thepair of retainers 208 a, 208 b, further away from the tear, pulls thebetter quality tendon tissue 9 into the decorticated trough 253 toreattach the tissue 9 to the bone 15.

As illustrated in FIG. 91, the physician then withdraws the deliverydevice 267 from the tendon tissue 9, leaving the fastener 21 in the bone15. At this step, the suture 11 passes from the fastener 21 through thetendon tissue 9 to the retainer 208 a. Referring to FIG. 92, thephysician then advances the retractable needle 263 out of the cannula215 by pushing the thumb pad 211 from its retracted position to itsextended position. To avoid having the suture 11 extending from thedelivery device 267 such that it is surrounded by the sharpened tip 233,the physician changes the position of the suture 11 relative to thesharpened tip 233 such that it passes through the slots 235, 241. Forexample, the physician can gently grasp the free end 115 of the suture11 and apply tension to the suture 11 while slightly rotating the handle210 around its longitudinal axis until the suture 11 moves along thecircumference of the sharpened tip and enters the slots 235, 241.

To manipulate the suture 11 through the slots 235, 241, the physiciancan instead rotate the handle 210 until the suture 11 is lined up withthe slots 235, 241. By advancing the delivery device 267 and extendingthe needle 263 such that the suture 11 passes into the slots 235, 241,the physician clears the suture 11 away from the sharpened tip 233. Thephysician then positions the sharpened tip 233 of the needle 263 againstthe tendon tissue 9 with the suture 11 moved away from the sharpened tip233. In this position, the suture 11 is not between the sharpened tip233 and the tendon tissue 9 and will not thereby be damaged (forexample, cut by the sharpened tip 233) when the needle is pressed intothe tendon tissue 9. The physician places the needle 263 adjacent to thebetter quality tendon tissue 9.

Referring to FIG. 93, the physician grasps the handle 210 and pushes thedelivery device 267 in the direction of the tendon tissue 9 to drive theneedle 263 through the tendon tissue 9 until the first barbed retainer208 a has completely passed through the tendon tissue 9. In particular,the barb 217 of the retainer 208 a is positioned within or through thetendon tissue 9. The suture 11 now extends from the fastener 21 throughthe tendon tissue 9, and back into the tendon tissue 9 to the retainer208 a and back to the delivery device 267.

Referring also to FIGS. 94 and 95, the physician withdraws the needle263 after placing the first retainer 208 a. By withdrawing the needle263, the barb 217 catches the tendon tissue 9 and remains caught againstthe tendon tissue 9 after the needle 263 is withdrawn. The firstretainer 208 a is flush against the tendon tissue 9, or alternatively,within the tendon tissue 9. As the physician further withdraws theneedle 263, tension in the suture 11 pulls the second retainer 208 b andthe slip knot 35 out of the needle 263.

Although both retainers 208 a, 208 b are illustrated as having the barb217, it is not necessary in all circumstances to provide the secondretainer 208 b with a tissue-catching member such as the barb 217.Because the first retainer 208 a is positioned against the tissue 9,withdrawing the needle 263 from the first retainer 208 a causes tensionin the suture 11 that pulls the second retainer 208 b from the needle263 without the barb 217 being used. However, to reduce manufacturingcosts and inventory costs, for example, the second retainer 208 b can bebarbed such that it is the same part as the first retainer 208 a.

Moreover, the barb 217 can be made of a bioabsorbable material such thatit is absorbed by the tissue and does not remain as a potential tissueirritant. The bioabsorbable materials can include a therapeutic agent totreat the injury, promote healing, or provide a preventativeanti-bacterial effect. If the physician has placed an absorbable tube358 between the fastener 21 and the first retainer 208 a, when thephysician withdraws the needle 263, the tube 358 also is pulled out ofthe needle 263 by the interaction of the retainer 208 a and the tissue 9such that the tube 358 is positioned in proximity to the first retainer208 a. If the physician has also placed an absorbable tube 358 betweenthe two retainers 208 a, 208 b, when the physician further withdraws theneedle 263, the tension in the suture 11 that pulls the second retainer208 b out of the needle 263 also pulls the second absorbable tube 358out of the needle 263.

Referring to FIGS. 96 and 97, the physician tightens the slip knot 35,optionally using a knot pusher, as discussed above, to press the secondretainer 208 b firmly against the tendon 9, which presses the tendontissue 9 firmly against the bone 15 within the decorticated trough towhich it is being reattached. As the slip knot 35 is tightened, thedistance between the retainers 208 a, 208 b is reduced and the distancebetween the fastener 21 and the retainers 208 a, 208 b is reduced. Inreducing these distances, the tendon tissue 9 is pulled into thedecorticated trough 253 and into contact with the bone tissue adjacentto the fastener 21. Moreover, the retainers 208 a, 208 b are pressedflush against the tendon tissue 9 to have a low profile, t. In thismanner, even if there initially was insufficient tendon tissue orinsufficient quality tendon tissue near the bone, the surgical assembly205 pulls the detached tendon tissue 9 into the decorticated trough 253such that quality tendon tissue 9 is reattached. After tightening theslip knot 35, the physician cuts the suture 11 adjacent to the slip knot130 and removes the delivery device 267.

Referring to FIGS. 98 and 99, a delivery device 300 is used to place thefastener 21 and a single barbed retainer 208 a instead of two barbedretainers 208 a, 208 b. In this embodiment, both the fastener 21 and theretainer 208 a are placed between the bone 15 and the tissue that isbeing reattached to the bone 15 (as illustrated in FIG. 94). The suture11 passes though and over the tissue between the fastener 21 and theretainer 208 a to compress the tissue against the bone 15. Because thereis only one retainer 208 a, which is positioned under the tendon, onlythe slip knot 35 remains on the outer or upper surface of the tendon 9.

Referring to FIG. 100, a delivery device 471 for placing fasteners 405,406 joined by the suture 11 and the slip knot 35 includes a cannula 421,a handle 425, and a thumb activated pusher rod 431. The cannula 421 andthe fastener 406 are keyed to limit relative rotation.

For example, referring to FIGS. 101-104, a bore 433 of the cannula 421is rectangular and the fastener 406 is rectangular along its entirelength. To provide the rectangular shape to the shaped fastener 406, thethreads are machined to have rectangular sides. The fastener 405 has arectangular head 434. Referring to FIGS. 101-103, the fastener 406 andthe bore 433 each have a pair of generally straight parallel walls 435,436, respectively, and a pair of curved, oppositely placed walls 447,452, respectively. The straight walls 435 of the fastener 406 arealigned with the straight walls 436 of the cannula 421 to preventrotation of the fastener 406 when it is positioned within the shapedbore 433 of the shaped cannula 421. The threads are flattened, cut orotherwise shaped along the entire length of the shank or along only aportion of the length of the shank. The fastener 406 has a slightlysmaller cross-sectional profile such that the fastener 406 slidessmoothly within the bore 433 of the cannula 421. As illustrated in FIG.104, the cannula 421 includes a slot 457 along its length through whichthe suture 11 passes.

In another implementation, the cannula 421 and the fastener 406 areformed with mating polygonal cross sections to limit relative rotation.Thus, for example, the bore 433 of the cannula 421 can be hexagonal andthe fastener 406 can be hexagonal along its entire length. To providethe hexagonal shape to the shaped fastener 406, the threads are machinedto have hexagonal sides. Additionally, in this example, the fastener 405has a hexagonal head 434.

To place the fasteners 405 and 406, the physician places the firstfastener 405 through the tendon tissue 9 into the bone 15 in ananalogous manner as described above. The physician advances the shapedfastener 406 in the shaped bore 433 of the cannula 421 by advancing thethumb-activated pusher rod 431 from a first retracted position to asecond extended position. In the second, extended position the shapedfastener 406 is advanced such that the distal end of the fastener 406extends out of the cannula 421 and a portion of the shank remains keyedwithin the shaped bore 433. The physician then presses the shapedfastener 406 through the tendon tissue 9 and screws it into the bone 15,as described above. Because the fastener 406 is keyed to the shaped bore433 of the cannula 421 because of the mating shape, the shaped fastener406 will not rotate relative to the cannula 421. The ability of theshaped fastener 406 not to rotate relative to the cannula 421 limits theamount of twisting that is imparted in the suture 11 as well as allowsthe shaped fastener 406 to be advanced within the cannula 421 and berotated with the cannula 421. The physician then withdraws the deliverydevice 471, which pulls the slip knot 35 from the cannula 421, tightensthe slip knot 35 against the tissue 9 using an optional knot pusher, andcuts the suture 11 at a position adjacent proximal to the slip knot 35.

Referring to FIG. 105, in another implementation for securing softtissue 262 to bone 264, a suture 266 is attached to two fixation membersin the form of a first fastener 270 and a second fastener 272. Thefasteners 270, 272 are, for example, TAG WEDGE bone anchors availablefrom Smith & Nephew, Inc. Endoscopy Division, Andover, Mass. Other boneanchors known in the art can be employed as the fasteners 270, 272.Suture 266 has a first end 274 fixed to the fastener 270, a second freeend 276, and a slip knot 268, formed as described above for slip knot28. Suture 266 preferably passes through a separate suture loop 278,rather than through the member 272 itself. Suture loop 278 acts as agood pulley allowing suture 266 to slide relative to suture loop 278.

In use, the user forms bone holes 280, 282 in bone 264. The user thenimplants the fastener 270 in bone hole 280, with suture 266 alreadythreaded as shown, followed by implanting the fastener 272 in bone hole282. The user then pulls on free end 276 of suture 266, which bringssoft tissue 262 against bone 264. Slip knot 268 limits loosening ofsuture 266. By using suture loop 278, suture 266 is not located withinbone hole 282 in use thus limiting the possibility of trapping suture266 against wall 284 of bone hole 282. If suture 266 were trapped inbone hole 282, pulling free end 276 of suture 266 would not result inshortening the length of suture between fasteners 270, 272, which actsto secure soft tissue 262 against bone 264.

Referring to FIG. 106, a knee joint 2600 includes a first meniscus 2605,a second meniscus 2610, a first ligament 2615, and a second ligament2620, the lateral collateral ligament. The first meniscus 2605 and thefirst ligament 2615 illustrate the normal position of the meniscus andligament relative to each other and to an upper surface 2625 of thetibia 2630. In contrast, the second ligament 2620 extends outwardly fromits normal position due to laxity in the ligament 2620. As a result ofthe laxity in the second ligament 2620, the second meniscus 2610 isdislodged from its normal position relative to the upper surface 2625 ofthe tibia 2630.

Referring to FIGS. 107-109, a surgical assembly 2640 used to correctlaxity in the ligament 2620 includes a surgical device 2645 and adelivery device 2650. The surgical device 2645 includes a fixationmember in the form of a fastener 2655, a fixation member in the form ofa retainer 2660, and a flexible member, such as a suture 2665. Thesuture 2665 couples the fastener 2655 and the retainer 2660, and is tiedin a limiting element such as a slip knot 2670 such that the distancebetween the fastener 2655 and the retainer 2660 can be shortened but notlengthened by pulling on a free end 2675 of the suture 2665. Thefastener 2655 includes a head 2680 and a shank 2685. The head 2680includes an opening 2690 through which the suture 2665 passes. The shank2685 includes circumferential ridges 2695 that resist pullout of thefastener 2655 when the fastener 2655 is implanted in bone. The retainer2660 includes a pair of openings 2700 through which the suture passesand a tab 2705 that extends from the retainer 2660. The retainer 2660 isa low profile retainer and has a thickness of between approximately 0.5and 2.5 millimeters, and more particularly of approximately 2millimeters.

The delivery device 2650 includes a handle 2710 and a cannula 2715 thatextends from the handle 2710. The handle 2650 includes an opening 2720in which a thumb switch 2725 slides to advance and retract a pusher tube2730 that is connected to the thumb switch 2725. The cannula 2715includes an inner lumen 2735 that extends from the opening 2720 in thehandle 2650 to a sharp, distal tip 2740 at a curved distal end 2742. Alongitudinal slot 2745 opens from outside the cannula 2715 into theinner lumen 2735. The inner lumen 2735 receives the fastener 2655, theretainer 2660, the suture 2665, and the slip knot 2670. The suture 2665is placed first within the inner lumen 2735 and pulled through thehandle 2710. The slip knot 2670 is placed next within the inner lumen2735. The fastener 2665 is placed next within the inner lumen 2735 in anorientation with the shank 2685 distal to the head 2680. Finally, theretainer 2660 is placed within the inner lumen 2735 with the tab 2705passing through the longitudinal slot 2745.

The suture 2665 extends through the cannula 2715 and the handle 2710such that the free end 2675 passes outside of the delivery device 2650.The cannula 2715 also includes a stop 2750 positioned within the innerlumen 2735 between the fastener 2655 and the retainer 2660. Referringparticularly to FIG. 109, the stop 2750 is cut from the cannula and canbe pressed down in a first direction, a, by the exertion of forceagainst the stop, such as by advancing the fastener 2655 distally overthe stop 2750. The necessity to apply force to pass the fastener 2655over the stop 2750 prevents the fastener 2655 from being accidentallydislodged. Although the stop 2750 can be pressed forward in the firstdirection, a, the stop 2750 cannot easily, if at all, be pressedbackward in a second opposite direction, b.

To dislodge the fastener 2655 from the cannula 2715, the physicianadvances the thumb switch 2725, which advances the pusher tube 2730 andforces the fastener 2655 over and past the stop 2750. The stop 2750prevents the fastener 2655 from being pushed back into the cannula 2715once it is pushed distal of the stop 2750. Because the stop 2750prevents backwards movement of the fastener 2655, the delivery device2650 can be used to press the fastener 2655 into bone tissue, asdescribed in more detail below.

Referring to FIG. 110, the physician initially accesses the knee joint2600, for example, using arthroscopic techniques, and drills a guidehole 2755 into the upper surface 2625 of the bone 2630 into which thefastener 2655 is to be placed. The physician then advances the deliverydevice 2650 into the knee joint 2600 and positions the cannula 2715underneath the second meniscus 2610 until the sharp, distal tip 2740 ispressed against the ligament 2620. The physician then advances thecannula 2715 into the second ligament 2620 by forcing the sharp, distaltip 2740 through the ligament 2620. The physician continues to advancethe cannula 2715 sufficiently such that the retainer 2660 is pushedcompletely through the ligament 2620. The physician then retracts thedelivery device 2650 enough to pull the cannula 2715 out of the ligament2620. In pulling back the cannula 2715, the tab 2705 that extends fromthe retainer 2660 catches the ligament 2620, thereby dislodging theretainer 2660 from the cannula 2715.

Referring to FIG. 111, the physician next positions the delivery device2650 within the knee joint 2600 such that the sharp, distal tip 2740 isbrought up to or inserted into the guide hole 2755. With the tip 2740 inthis position, the physician advances the thumb switch 2725 to push thefastener 2655 out of the lumen 2735 and into the guide hole 2755.

Referring to FIG. 112, the physician then presses the fastener 2655deeper into the guide hole 2755. To press the fastener 2655 into theguide hole 2755, the physician rests the stop 2750 against the head 2680of the fastener 2655 and applies force to the delivery device 2650.Because the stop 2750 will not bend backwards, the force applied to thestop 2750 will be transmitted to the fastener 2655 and will therebyforce the fastener 2655 into the guide hole 2755. The physician may needto further advance the thumb switch 2725 to advance the pusher rod 2730to ensure that the fastener 2655 is completely within the guide hole2755.

Referring to FIG. 113, after placing the fastener 2665, the physicianwithdraws the delivery device 2650 from the knee joint 2600, leaving thefastener 2655 within the bone 2630 and the retainer 2660 against theligament 2620. The slip knot 2670 is positioned underneath the meniscus2610 between the retainer 2660 and the fastener 2655 and the remainderof the suture 2665 extends out of the knee joint 2600. The fastener 2655is positioned within the bone 2630 at an angle 6 that is at ninetydegrees or less relative to the suture 2665 that passes between theretainer 2660 and the fastener 2655. An angle 6 of ninety degrees orless opposes a force that would tend to pull the fastener 2655 out ofthe bone 2630. The physician next pulls the free end 2675 of the suture2665 in a direction, F, which shortens the distance between the fastener2655 and the retainer 2660 as the slip knot 2670 is pulled toward thefastener 2655. Referring to FIG. 114, shortening the distance betweenthe fastener 2655 and the retainer 2660 pulls the retainer 2660 in thedirection of the fastener 2655, thus, moving the ligament 2620 and themeniscus 2610 inward, which corrects the misplacement of the meniscus2610. The physician then cuts the suture 2665 at a position adjacent to,but proximal of, the slip knot 2670, which tends to remain underneaththe meniscus 2610.

FIGS. 106-114 illustrate a method of repairing the laxity in theligament 2620 and the displaced meniscus 2610 by placing the retainer2660 before the fastener 2655. Nonetheless, the order in which theretainer 2660 and the fastener 2655 are placed can be reversed. Forexample, by modifying the cannula 2715 and placing the retainer 2660 inthe cannula 2715 before the fastener 2655 is placed in the cannula 2715,the fastener 2655 can be placed in the bone 2630 before the retainer2660 is placed against the ligament 2620. In particular, referring toFIG. 115, a cannula 2715 a has a stop 2750 a positioned closer to asharp, distal tip 2740 a than to stop 2750 of the cannula 2715. Byplacing the stop 2750 a in a more distal position, the stop 2750 alimits the likelihood that the fastener 2655 will retract into thecannula 2715 a when it is forcibly inserted into the guide hole 2755.

Referring to FIG. 116, in the manner described above, the physicianinitially accesses the knee joint 2600 and drills a guide hole 2755 intothe upper surface 2625 of the bone 2630 into which the fastener 2655 isto be placed. The physician then advances the delivery device 2650 ainto the knee joint 2600 and positions the delivery device 2650 a withinthe knee joint 2600 such that the fastener 2655 and the sharp, distaltip 2740 a are inserted into the guide hole 2755. With the tip 2740 a inthis position, the physician advances the delivery device 2650 a tofurther press the fastener 2655 into the guide hole 2755. The physicianthen retracts the delivery device 2650 a from the guide hole 2755.Because the fastener 2655 includes circumferential ridges 2695 that arewedged into the bone 2630 surrounding the guide hole 2755, the fastener2655 will resist pullout when the delivery device 2650 a is retracted.To ensure that the fastener 2655 is placed sufficiently within the guidehole 2755, the physician presses the fastener 2655 deeper into the guidehole 2755. Because the stop 2750 a will not bend backwards, the forceapplied to the stop 2750 a will be transmitted to the fastener 2655 andwill thereby force the fastener 2655 further into the guide hole 2755.

Referring to FIG. 117, the physician next positions the cannula 2715 aunderneath the second meniscus 2610 and advances the cannula until thesharp, distal tip 2740 a is pressed against the ligament 2620. Thephysician then advances the cannula 2715 a into the ligament 2620 byforcing the sharp, distal tip 2740 a through the ligament 2620 whilepressing the thumb switch 2725 a forward to advance the pusher rod 2730a and pass the retainer 2660 over the stop 2750 a. The physiciancontinues to advance the cannula 2715 a sufficiently such that theretainer 2660 is pushed completely through the ligament 2620. Thephysician then retracts the delivery device 2650 a enough to pull thecannula 2715 a out of the ligament 2620. In pulling back the cannula2715 a, the tab 2750 a that extends from the retainer 2660 catches theligament 2620, thereby dislodging the retainer 2660 from the cannula2715 a.

As described above with respect to FIG. 113, after placing the retainer2660, the physician withdraws the delivery device 2650 a from the kneejoint 2600, leaving the fastener 2655 within the bone 2630 and theretainer 2660 against the ligament 2620. The fastener 2655 is positionedwithin the bone 2630 at an angle, δ, that is, at ninety degrees or lessrelative to the suture 2665 that passes between the retainer 2660 andthe fastener 2655. The slip knot 2670 is positioned underneath themeniscus 2610 between the retainer 2660 and the fastener 2655 and theremainder of the suture 2665 extends out of the knee joint 2600. Thephysician next pulls the free end 2675 of the suture 2665 in adirection, F, which shortens the distance between the fastener 2655 andthe retainer 2660 as the slip knot 2670 is pulled toward the fastener2655. As described above with respect to FIG. 114, shortening thedistance between the fastener 2655 and the retainer 2660 pulls theretainer 2660 in the direction of the fastener 2655. Pulling theretainer 2660 pulls the ligament 2620 and the meniscus 2610 inwardly,which corrects the misplacement of the meniscus 2610. The physician thencuts the suture 2665 at a position adjacent to, but proximal of, theslip knot 2670, which tends to remain underneath the meniscus 2610.

Referring to FIGS. 118-123, one of the fixation members 2805 of a repairdevice 2800 can be shaped like a button and passed through a channel forrepairing a tear in soft tissue. Referring to FIG. 118, a surgicaldevice 2800 includes a fixation member such as a retainer 2805 in theshape of a button, a fixation member such as a retainer 2810, and aflexible member, such as a suture 2815. The suture 2815 couples theretainer 2805 and the retainer 2810, and is tied in a slip knot 2820such that the distance between the retainer 2805 and the retainer 2810can be shortened but not lengthened by pulling on a free end 2825 of thesuture 2815. The retainer 2805 includes a pair of width edges 2830, apair of length edges 2835, an upper surface 2840, a lower surface 2845,a pair of inner openings 2850 passing between the upper surface 2840 andthe lower surface 2845, and a pair of outer openings 2855 passingbetween the upper surface 2840 and the lower surface 2845. The retainerhas a length, L, of between approximately 18-22 mm and a width, W, ofbetween approximately 2-6 mm. The suture 2815 passes through the inneropenings 2850. A pair of sutures 2860 pass through each of the outeropenings 2855 and are used to flip the retainer 2805, as describedbelow. The retainer 2810 includes a pair of openings 2865 through whichthe suture 2815 passes. The retainer 2810 is a low profile retainer andhas a thickness, T, of between approximately 0.5 and 2.5 millimeters,and more particularly of approximately 2 millimeters.

Referring to FIGS. 119 and 120, the physician uses a surgical device torepair, for example, a tear in the meniscus 2870 of the knee joint 2875.Initially, the physician makes a surgical incision on the anteriorsurface of the lower leg 2880 and passes a drill 2883 through the tibia2885, the meniscus 2870, and the femur 2890 to form a channel 2895through the tibia 2885, the meniscus 2870, and the femur 2890. The drill2883 includes a head 2897 and a shank 2900. The head 2897 includes anopening 2905 for receiving sutures 2860 and the shank 2900 includes acutting section 2910 and a smooth section 2915.

Referring also to FIG. 121, once the physician passes the cuttingsection 2910 through the femur 2890 and the skin 2920, the physicianremoves the drill 2883 from the handle or other device used to advancethe drill 2883. The physician then passes the free ends of the sutures2860 coupled to retainer 2805 through the opening 2905 and advances thedrill 2883 along the channel 2895 until the drill 2883 is completelyadvanced through and out of the channel 2895. The sutures 2860 nowextend between a first opening 2925 of the channel 2895 and a secondopening 2930 of the channel 2895. Specifically, free ends 2935 of thesutures 2860 extend from the second opening 2930. The mid-section of thesutures 2860 extend from the first opening 2925 and pass through theouter openings 2855 of the retainer 2805. The physician then inserts theretainer 2805 lengthwise into the channel 2895 and pulls the free ends2935 of the sutures 2860 to pull the retainer 2805 into the channel2895. The physician continues to pull the free ends 2935 until theretainer 2805 passes through the tibia 2885 and the meniscus 2870, andis within the knee joint 2875.

Referring to FIG. 122, to position the retainer 2805 against themeniscus 2870 within the knee joint 2875, the physician pulls on thesuture 2815, which pulls the retainer 2805 back in the direction of themeniscus 2870 and the tibia 2885. To ensure that the retainer 2805 isnot pulled back into the channel 2895, the physician changes theorientation of the retainer 2805 to be transverse to the channel 2895 bypulling on the sutures 2860. The physician pulls on one of the sutures2860 more than the other suture 2860 to rotate the retainer 2805 withinthe joint. The physician then pulls the free end 2825 of the suture2815, which moves the slip knot 2820 to shorten the distance between theretainer 2805 and the retainer 2810. The physician continues to pull onthe free end 2825 until the retainer 2810 is pressed against the firstopening 2925, which presses the retainer 2805 against the meniscus 2870to repair the tear in the meniscus 2870. Referring to FIG. 123, tocomplete the procedure, the physician cuts the suture 2815 adjacent tothe slip knot 2820 and pulls one free end 2935 of each suture 2860,which pulls the sutures 2860 out of the retainer 2805.

The surgical device 2800 also can be used in a similar manner to repairother tissue within the body. For example, referring to FIGS. 124-127,the surgical device 2800 can be used to repair a tom rotator cuff 2950in the shoulder joint 2953. Referring to FIG. 124, the physicianinitially makes an incision to access the rotator cuff 2950 and thenuses the drill 2883 to drill a channel 2955 through the rotator cuff2950, the humerus head 2957, and the skin 2960. When the cutting section2910 passes through the skin 2960, the physician removes the tool (forexample, handle) used to drive the drill 2883 and passes the sutures2860 through the opening 2905.

Referring to FIG. 125, the physician then advances the drill 2883completely through the channel 2955 pulling the free ends of the sutures2860 couple to openings 2855 of retainer 2805 through the skin 2960. Thesutures 2860 extend between a first opening 2962 of the channel 2955 anda second opening 2965 of the channel 2955. The second opening 2965 is inthe skin 2960. Specifically, free ends 2935 of the sutures 2860 extendfrom the second opening 2930. The physician then inserts the retainer2805 lengthwise into the channel 2955 and pulls the free ends 2935 ofthe sutures 2860 to pull the retainer 2805 through the channel 2955. Thephysician continues to pull the free ends 2935 until the retainer 2805passes through the rotator cuff 2950 and the humerus head 2957 and ispositioned between the skin 2960 and the humerus head 2957.

Referring to FIG. 126, to position the retainer 2805 against the humerushead 2957, the physician pulls on the suture 2815, which pulls theretainer 2805 in the direction of the humerus head 2957. To ensure thatthe retainer 2805 is not pulled back into the channel 2955, thephysician changes the orientation of the retainer 2805 to be transverseto the channel 2955 by pulling on the sutures 2860. To change theorientation, the physician can pull on one of the sutures 2860 more thanthe other suture 2860 to rotate the retainer 2805. The physician thenpulls the free end 2825 of the suture 2815, which moves the slip knot2820 to shorten the distance between the retainer 2805 and the retainer2810. The physician continues to pull on the free end 2825 until theretainer 2810 is pressed against the first opening 2962, which pressesthe retainer 2805 against the rotator cuff 2950 to repair the tear.

Referring to FIG. 127, to complete the procedure the physician cuts thesuture 2815 adjacent to the slip knot 2820 and pulls one free end 2935of each suture 2860, which pulls the sutures 2860 out of the retainer2805.

Other embodiments are within the scope of the following claims. Forexample, although in certain embodiments the fastener is generallydescribed and illustrated as a screw, other implementations of thefastener include an anchor, pound-in screw, or any other configurationthat is insertable and retained within bone. The screw and cannula canbe coupled by other than hexagonal shapes.

The fixation members, limiting elements, and flexible members of theabove embodiments can be formed of a biodegradable material.

The devices and techniques described above can be applied to otheranatomical regions to reattach tissue to bone or repair a tear in softtissue, such as the biceps tendons, the lateral collateral ligament, themedial collateral ligament, the popliteal ligament, and the hip.

1. An apparatus, comprising: first and second fixation members, and aflexible element coupling the first and second fixation members, theflexible element forming a knot having, in order, along a length of theflexible element, a first section on a first side of the first fixationmember, a second section on a second side of the first fixation member,a third section that passes under the first section, a fourth sectionthat passes over the first section, a fifth section that passes underand over the second section forming a loop, a sixth section that passesover the first section, a seventh section that passes under the firstsection, and an eighth section that passes under the second section andthrough the loop.
 2. The apparatus of claim 1, further comprising adelivery device within which the first and second fixation memberscoupled by the flexible element are received.
 3. The apparatus of claim2, wherein at least a portion of the knot is spaced from each of thefixation members.
 4. The apparatus of claim 2, wherein at least aportion of the knot is off of each of the fixation members.
 5. Theapparatus of claim 1, further comprising a cannula within which thefirst and second fixation members coupled by the flexible element arereceived.
 6. The apparatus of claim 1, further comprising a deliverydevice, the delivery device comprising a handle and a cannula, thecannula extending from the handle and including a longitudinal channelwithin which the first and second fixation members are slidablyreceived.
 7. The apparatus of claim 6, further comprising a memberslidably positioned within the cannula, the member including afinger-engageable element for advancing and retracting the member withinthe cannula.
 8. The apparatus of claim 7, wherein the member engages atleast one of the first and second fixation members to deploy the atleast one of the first and second fixation member from the cannula. 9.The apparatus of claim 1, wherein the knot is formed around a portion ofthe flexible element and wherein at least a portion of the knot is notformed around either of the first and second fixation members.
 10. Theapparatus of claim 1, wherein at least one of the first and secondfixation members defines a through hole for receiving the flexibleelement.
 11. The apparatus of claim 10, wherein the flexible elementpasses through the through hole in the at least one of the first andsecond fixation members.
 12. The apparatus of claim 1, wherein at leastone of the first and second fixation members comprises a T-shape. 13.The apparatus of claim 1, wherein one of the first and second fixationmembers is fixedly attached to the flexible element.
 14. The apparatusof claim 1, wherein one of the first and second fixation members isslidably attached to the flexible element.
 15. The apparatus of claim 1,wherein the flexible element comprises a suture.
 16. The apparatus ofclaim 1, wherein no portion of the flexible element extends from eitherfixation member to the other fixation member and back to the originalfixation member.
 17. The apparatus of claim 1, wherein the first andsecond fixation members comprise substantially the same shape.
 18. Theapparatus of claim 1, further comprising a delivery device, the deliverydevice comprising: a handle, a cannula, the cannula extending from thehandle and including a longitiudinal slot in the cannula along at leasta portion of the length of the cannula, and a pusher member slidablypositioned within the cannula, the pusher member including afinger-engageable element for advancing and retracting the pusher memberwithin the cannula, wherein the first and second fixation memberscoupled by the flexible element are slidably disposed within the cannulasuch that upon a(advancement of the pusher member, at least one of thefirst and second fixation members is deployed from the cannula.
 19. Anapparatus, comprising: a delivery device comprising: a handle, a cannulaextending from the handle, and a pusher member slidably positionedwithin the cannula, the pusher member including a finger-engageableelement for advancing and retracting the pusher member within thecannula; first and second fixation members; and a flexible elementcoupling the first and second fixation members, the flexible elementforming a knot having, in order, along a length of the flexible element,a first section on a first side of the first fixation member, a secondsection on a second side of the first fixation member, a third sectionthat passes under the first section, a fourth section that passes overthe first section, a fifth section that passes under and over the secondsection forming a loop, a sixth section that passes over the firstsection, a seventh section that passes under the first section, and aneighth section that passes under the second section and through theloop, wherein the first and second fixation members coupled by theflexible element are slidably disposed within the cannula such that withadvancement of the pusher member at least one of the first and secondfixation members is deployed from the cannula.
 20. The apparatus ofclaim 19, wherein at least one of the first and second fixation membersdefines a through hole for receiving the flexible element.
 21. Theapparatus of claim 20, wherein the flexible element passes through thethrough hole in the at least one of the first and second fixationmembers.
 22. The apparatus of claim 19, wherein at least one of thefirst and second fixation members comprises a T-shape.
 23. The apparatusof claim 19, wherein one of the first and second fixation members isfixedly attached to the flexible element.
 24. The apparatus of claim 19,wherein one of the first and second fixation members is slidablyattached to the flexible element.
 25. The apparatus of claim 19, whereinthe flexible element comprises a suture.
 26. The apparatus of claim 19,wherein no portion of the flexible element extends from either fixationmember to the other fixation member and back to the original fixationmember.
 27. The apparatus of claim 19, wherein the first and secondfixation members consist essentially of the same shape.
 28. An apparatusfor arthroscopically repairing a tear in the meniscus of a knee of ahuman patient, comprising: a handle adapted to be held by a surgeonoutside the body of the patient; an elongated cannula adapted to extendfrom the handle to within the patient, the cannula being attached to thehandle; first and second fixation members having an elongated shape,each of the first and second fixation members being preformed prior touse in a form for use, the fixation members being slidably disposedwithin the cannula; a flexible element coupling the first and secondfixation members, the flexible element forming a slip knot having, inorder, along a length of the flexible element, a first section on afirst side of the first fixation member, a second section on a secondside of the first fixation member, a third section that passes under thefirst section, a fourth section that passes over the first section, afifth section that passes under and over the second section forming aloop, a sixth section that passes over the first section, a seventhsection that passes under the first section, and an eighth section thatpasses under the second section and through the loop; at least oneelongated pusher member slidably positioned within the cannula, thepusher member including a finger-engageable member for advancing andretracting the pusher member, the finger-engageable member being adaptedto be engageable by the surgeon from outside the body of the patient,the pusher member adapted to engage at least one of the first and secondfixation members such that upon advancement of the pusher member atleast one of the fixation members is deployed from the cannula.
 29. Theapparatus of claim 28, wherein the first fixation member is fixedlyattached to the flexible element.
 30. The apparatus of claim 28, whereinthe second fixation member is slidably attached to the flexible element.31. The apparatus of claim 28, wherein the second fixation member isfixedly attached to the flexible element such that the length of theflexible element between the slip knot and the second fixation memberremains substantially constant.
 32. The apparatus of claim 28, whereinthe flexible element comprises a suture.